FDA Adverse Event
Other
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 250408
·
Received November 17, 1999
Report
- Report Number
- 2210968-1999-00558
- Event Type
- Other
- Date Received
- November 17, 1999
- Report Date
- November 11, 1999
- Manufacturer
- ETHICON, INC. SAN ANGELO
- Product Code
- GAM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
IT WAS ALLEGED BY THE ATTORNEY THAT THE PLAINTIFF DEVELOPED AN INFECTION AS A RESULT OF A SURGERY WHERE VICRYL SUTURES WERE USED. THE SURGERY WAS BILATERAL REMOVAL OF SILICONE BREAST IMPLANTS WITH CAPSULECTOMY AND BILATERAL MASTOPEXY, AND WAS PERFORMED IN 08/1994.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE Implant | SUTURE, ABSORBABLE | GAM | ETHICON, INC. SAN ANGELO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |