FDA Adverse Event
Other
Summary report: N
PULSE CARE MEDICAL LLC
MDR report key: 2956720
·
Received January 6, 2006
Report
- Report Number
- 2956720
- Event Type
- Other
- Date Received
- January 6, 2006
- Date of Event
- June 30, 2005
- Report Date
- July 8, 2005
- Manufacturer
- PULSE CARE MEDICAL LLC
- Product Code
- KPE
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICAL THERAPIST
Narratives
Description of Event or Problem · 1
PULSE IRRIGATION - WASTE BAG LEAKS. SEAL ON BODY OF PT NOT LEAKING. PT HAD WOUND THAT WAS PULSED IRRIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE CARE MEDICAL LLC | PLASTIC BAG | KPE | PULSE CARE MEDICAL LLC | ADH 200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |