D
Patient 1
IT WAS REPORTED THAT THE BATTERY OF A RENASYS TOUCH DEVICE NO LONGER HOLDS THE CHARGE. THE TREATMENT WAS INTERRUPTED WHILE WAITING FOR ANOTHER DEVICE IN EXCHANGE.
MAUDE MDR 9881243
- MDR report key
- 9881243
- Report number
- 8043484-2020-00214
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-28
- Date received
- 2020-03-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DR SARAH FREESTONE
- Address
- 101 HESSLE ROAD HULL HU3 2 UK
- Phone
- 44-44-0447
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RENASYS TOUCH DEVICE & POWER SUP | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | SMITH & NEPHEW MEDICAL LTD. | OMP | 66801280 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-25 | 0 |