FDA Adverse Event
Malfunction
Summary report: N
LISTER BANDAGE SCISSORS
MDR report key: 1749620
·
Received July 6, 2010
Report
- Report Number
- 1749620
- Event Type
- Malfunction
- Date Received
- July 6, 2010
- Date of Event
- July 4, 2010
- Report Date
- July 6, 2010
- Manufacturer
- MILTEX INSTRUMENT CO.
- Product Code
- LRW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHEN EXTENDING A UTERINE INCISION DURING A C-SECTION DELIVERY, THE PHYSICIAN REPORTED DIFFICULTY USING THE LISTER BANDAGE SCISSORS. THE PHYSICIAN FOUND THE SCISSORS WERE DULL CAUSING A DELAY PRIOR TO REPLACEMENT. THE DELAY RESULTED IN PROLONGED TIME TO REMOVE A PRE-TERM BREECH BABY. MD REQUESTED REPLACEMENT SCISSORS AND PROCEEDED WITH DELIVERY AFTER THE SCISSORS ARRIVED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================CAUSED A DELAY FROM INCISION TO DELIVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LISTER BANDAGE SCISSORS | SCISSORS | LRW | MILTEX INSTRUMENT CO. | 5-550 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |