N
Patient 1
(B)(4).
MAUDE MDR 8198948
- MDR report key
- 8198948
- Report number
- 3010293992-2018-00124
- Event key
- 0
- Event type
- 3
- Date received
- 2018-12-27
- 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
- MS. JUDITH ANTLER
- Address
- YAD HARUZIM NETANYA, 42505 IS
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SAPPHIRE EXTERNAL BATTERY PACK | EXTERNAL BATTERY PACK | Q CORE MEDICAL LTD. | MRZ | 15079-111-0001-P2 | 0215 | Y | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-27 | 0 |
Event Narratives#
D
Patient 1
THE EVENT WAS REPORTED BY A CUSTOMER FROM THE USA: EXTERNAL BATTERY PACK OVERHEATING DUE TO POSSIBLE USER ERROR.