FDA Adverse Event
Malfunction
Summary report: N
NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS
MDR report key: 17530553
·
Received August 12, 2023
Report
- Report Number
- MW5137472
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- July 1, 2015
- Manufacturer
- KALYPTO
- Product Code
- OKO
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
FACILITY REPORTED THAT PUMP WAS USING TOO MANY BATTERIES; 3 PER DAY. THEY THOUGHT THE UNIT RAN WELL AND DID WHAT IT WAS SUPPOSED TO BUT IT WOULD DRAIN BATTERIES IN LESS THAN A DAY AND SHUT OFF. I REPLACED UNIT. NO INJURY ALLEGED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783641 | NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS | NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS | OKO | KALYPTO | P10001-K | 000054-054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |