FDA Adverse Event
Death
Summary report: N
SURGILENE, 4-0
MDR report key: 18132
·
Received December 1, 1994
Report
- Report Number
- MW1004257
- Event Type
- Death
- Date Received
- December 1, 1994
- Date of Event
- November 8, 1994
- Report Date
- November 22, 1994
- Manufacturer
- DAVIS & GECK, INC.
- Product Code
- GAW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WE ARE CONFIRMING OUR TELECON ON 1/23/95 CONCERNING THE EXTENSION TO 2/10/95 TO RESPOND TO YOUR INQUIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGILENE, 4-0 | SUTURE MATERIAL | GAW | DAVIS & GECK, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death| R |