FDA Adverse Event
Injury
Summary report: N
ETHILON NYLON SUTURE
MDR report key: 3851390
·
Received June 5, 2014
Report
- Report Number
- 2210968-2014-07174
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- November 9, 2014
- Report Date
- May 15, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 A PATIENT UNDERWENT A C-SECTION ON (B)(6) AND SUTURE WAS USED. SIX DAYS POST OPERATIVE, SHE DEVELOPED A PUERPERAL INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330144 | ETHILON NYLON SUTURE | SUTURE, NONABSORBABLE, SYNTHETIC | GAR | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |