N
Patient 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10-AUG-2018 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE BUMPER PAD. (B)(6).
MAUDE MDR 7807888
- MDR report key
- 7807888
- Report number
- 2531779-2018-15228
- Event key
- 0
- Event type
- 3
- Date received
- 2018-08-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KARIN SARGRAD
- Address
- 200 LAWRENCE DR WEST CHESTER PA 19380 US
- Phone
- 484-484-4843
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ANIMAS VIBE | INSULIN INFUSION PUMP | ANIMAS LLC | OYS | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-08-22 | 0 |
Event Narratives#
D
Patient 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10-AUG-2018.