FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 458897
·
Received May 9, 2003
Report
- Report Number
- 2210968-2003-00151
- Event Type
- Injury
- Date Received
- May 9, 2003
- Date of Event
- April 1, 2003
- Report Date
- April 10, 2003
- Manufacturer
- ETHICON, INC. SOMERVILLE
- Product Code
- GAM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT REPAIR IN 03/2003. IN 2003, PT PRESENTED WITH TEMPERATURE OF 99.5 AND LEFT KNEE WAS ASPIRATED. CULTURES WERE TAKEN AND WERE NEGATIVE. IN 04/2003. PT PRESENTED WITH TEMPERATURE OF 99.8 AND COMPLAINED OF NIGHT SWEATS. IN 04/2003 THE PT WAS TAKEN BACK TO SURGERY AND THE ACL GRAFT WAS REMOVED. THE GRAFT WAS CULTURED AND IT TESTED POSITIVE FOR STAPH. COAGULASE NEGATIVE. THE PT WAS PLACED ON IV ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. SOMERVILLE | NA | RL9046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |