D
Patient 1
IRRIGATOR WAS LEAKING WATER FROM THE BATTERY PACK COMPARTMENT. THIS WAS THE SECOND OCCURRENCE IN A ROW. THE STAFF ONLY RETAINED ONE OF THE TWO IRRIGATORS THAT LEAKED.
MAUDE MDR 1317629
- MDR report key
- 1317629
- Report number
- 1317629
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-01-23
- Date received
- 2009-02-11
- 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#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HYDRO-SURG PLUS | IRRIGATOR, LAPAROSCOPIC, BATTERY POWERED | DAVOL INC. | KQT | * | 0026880 | JUSDF003 | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-02-11 | 0 |