FDA Adverse Event
Injury
Summary report: N
SURGICAL GUT SUTURE - CHROMIC
MDR report key: 4810953
·
Received June 2, 2015
Report
- Report Number
- 2210968-2015-06548
- Event Type
- Injury
- Date Received
- June 2, 2015
- Report Date
- May 8, 2015
- Manufacturer
- ETHICON INC.
- Product Code
- GAL
- PMA / PMN Number
- K946173
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARPAL TUNNEL SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED INFLAMMATION, INFECTION OR DEHISCENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355643 | SURGICAL GUT SUTURE - CHROMIC | SUTURE, ABSORBABLE, NATURAL | GAL | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |