FDA Adverse Event
Injury
Summary report: N
POLYSORB SIZE 1
MDR report key: 1033782
·
Received April 25, 2008
Report
- Report Number
- 1219930-2008-00328
- Event Type
- Injury
- Date Received
- April 25, 2008
- Date of Event
- January 30, 2008
- Report Date
- April 3, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAM
- PMA / PMN Number
- K963253
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 04/25/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: "REMOVAL OF METALL OF AN INCOMPLEX, UNOBTRUSIVE INTRA MEDULLA NAIL ON A TIBIA". ACCORDING TO THE REPORTER: THERE WAS A "DEEP WOUND INFECT WITH INFECTION OF THE LIGAMENTUM PATELLAE (KNEE-JOINT). TWO REVISION SURGERIES WITH INSERTIN OF ANTIBIOTIC CARRIERS WERE NECESSARY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYSORB SIZE 1 | ABSORBABLE SYNTHETIC SUTURES | GAM | NORTH HAVEN - USS | A7H306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |