N
Patient 1
(B)(4). THIS SUMMARY REPORT IS PART OF THE 227 PILOT PROGRAM. (B)(4). NONE OF THE DEVICES WERE REPROCESSED AND REUSED. NO REMEDIAL ACTION WAS TAKEN.
MAUDE MDR 5612112
- MDR report key
- 5612112
- Report number
- 1219930-2016-00384
- Event key
- 0
- Event type
- 3
- Date received
- 2016-04-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- SHARON MURPHY
- Address
- 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ANOSCOPE AND ACCESSORIES | COVIDIEN, FORMERLY US SURGICAL A DIVISON | FER | SILSPT12TA | SILSPT12TA | * | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-27 | 0 |
Event Narratives#
D
Patient 1
THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS WHICH ARE ASSOCIATED WITH UNDESIRED DAMAGE OR BREAKAGE OF MATERIALS USED IN DEVICE CONSTRUCTION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. PATIENT INFORMATION WAS CONFIRMED FOR ONE EVENT. (B)(6).