STRATAFIX Symmetric PDS Plus · Suture, surgical, absorbable, polydioxanone
Ethicon Inc. · Adverse Event Without Identified Device or Use Problem
- Manufacturer contact t name
- Dr.
- Manufacturer contact state
- NJ
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Ciudad Juarez
- Manufacturer contact address 1
- 1000 Route 202
- Manufacturer contact pcity
- +1(303)5
- Event type
- Injury
- Report number
- 2210968-2026-07708
- Product problem flag
- N
- Date received
- 20260831
- PMA pmn number
- K182873
- Date of event
- 20260711
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 08869
- Manufacturer contact plocal
- +1(303)552-6892
- Noe summarized
- 1
- Manufacturer contact l name
- O'Mahony
- Manufacturer g1 postal code
- 32575
- Reporter country code
- US
- Date added
- 20260831
- Manufacturer contact f name
- Orla
- Previous use code
- I
- Suppl dates mfr received
- 08/07/2026
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260831
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260831
- Initial report to FDA
- No
- Manufacturer g1 country
- MX
- Manufacturer contact city
- Raritan
- MDR report key
- 50115276
- Date manufacturer received
- 20260713
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 32575
- Manufacturer g1 name
- Ethicon Inc.-Juarez
- Adverse event flag
- Y
- Single use flag
- Y
- Manufacturer g1 address 1
- Calle Durango #2751
- Manufacturer contact postal code
- 08869
- Suppl dates FDA received
- 08/31/2026
- Type of report
- Initial submission, Followup
- Source type
- Foreign, Health Professional, User facility, Company representation
- Device
- Device sequence number
- 252929
- Date received
- 20260831
- Brand name
- STRATAFIX Symmetric PDS Plus
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Manufacturer d name
- Ethicon Inc.
- Manufacturer d address 1
- 1000 Route 202
- Manufacturer d city
- Raritan
- Manufacturer d state
- NJ
- Manufacturer d zip code
- 08869
- Manufacturer d country
- US
- Manufacturer d postal code
- 08869
- Device operator
- HEALTH PROFESSIONAL
- Catalog number
- SXPP1A301
- Device availability
- No
- Device report product code
- NEW
- Device evaluated by manufacturer
- N
- Combination product flag
- Y
- UDI di
- 10705031227712
- UDI public
- 10705031227712
- Harmonized identifiers (openFDA)
- Device name
- Suture, Surgical, Absorbable, Polydioxanone
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4840
- Device class
- 2
- Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient
- Patient sequence number
- 1
- Patient problems
- Wound Dehiscence, Vomiting, Hernia