FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 1520600
·
Received October 30, 2009
Report
- Report Number
- 2210968-2009-01246
- Event Type
- Injury
- Date Received
- October 30, 2009
- Report Date
- September 29, 2009
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K946271
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 10/29/2009. 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
INTERNATIONAL CUSTOMER REPORTS IN THE PEER REVIEWED SURGICAL JOURNAL, (JOURNAL OF BONE AND JOINT SURGERY 2003, 85-A: 2006-2009) THAT A PATIENT PRESENTED WITH A GRANULOMA MIMICKING AN INFECTION. THE PATIENT UNDERWENT AN EXCISION AND DRAINAGE OF THE SURGICAL SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |