FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 3023441
·
Received March 27, 2013
Report
- Report Number
- 2210968-2013-02818
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- February 6, 2013
- Report Date
- March 4, 2013
- 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
- PHARMACIST
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 A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED THE PATIENT EXPERIENCED INFLAMMATION, PURULENT DRAINAGE, EXTRUSION OF THE SUTURE AT THE SUBCUTANEOUS LAYER, AND DELAYED HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126756 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |