FDA Adverse Event
Injury
Summary report: N
VICRYL POLYGLACTIN 910 SUTURE
MDR report key: 3870572
·
Received June 12, 2014
Report
- Report Number
- 2210968-2014-07537
- Event Type
- Injury
- Date Received
- June 12, 2014
- Report Date
- May 27, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED STAPHYLOCOCCUS AUREUS INFECTION AFTER WOUND CLOSURE DURING REMOVAL OF ORTHOPEDIC DEVICE. THE SURGEON OPINES THAT THE INFECTION DID NOT COME FROM THE SUTURE BUT FROM THE MEPILEX BAND-AID DRESSING AND SOLUTION NOT BEING APPLIED AS IT SHOULD WITH CREATION OF AIR BUBBLES THAT COULD CAUSE INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348518 | VICRYL POLYGLACTIN 910 SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MEPILEX |