D
Patient 1
THE PRODUCT INSULATION WAS ALLEGED TO HAVE HOLES IN IT RESULTING IN DAMAGE TO THE PT'S SMALL BOWEL DURING A LAPAROSCOPIC ADRENALECTOMY. COMPLAINANT SENT MDR REPORT TO FDA.
MAUDE MDR 281733
- MDR report key
- 281733
- Report number
- 1038548-2000-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2000-03-28
- Date received
- 2000-06-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LEIGH GAYLE, SPECIALIST
- Address
- 5175 S. ROYAL ATLANTA DR TUCKER GA 30084 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DIAMOND-LINE SWITCHBLADE METZENBAUM SCISSOR SHAFT | REUSABLE SWITCHBLADES | GENZYME SURGICAL PRODUCTS | GEI | 90-1050 | * | UNK | K930666 | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-06-14 | 0 | 1. O |