FDA Adverse Event
Malfunction
Summary report: N
STABILITY THREAD
MDR report key: 14401
·
Received June 29, 1994
Report
- Report Number
- MW1002641
- Event Type
- Malfunction
- Date Received
- June 29, 1994
- Date of Event
- May 9, 1994
- Report Date
- May 27, 1994
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- KDC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SURGEON STATED THAT EQUIPMENT WAS NOT FUNCTIONING CORRECTLY, REQUIRING THE USAGE OF SEVERAL OF EACH ITEM. (ALSO SEE 1002638, 1002639, 1002640, AND 1002642.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STABILITY THREAD | STABILITY THREAD | KDC | ETHICON ENDO-SURGERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |