FDA Adverse Event
Other
Summary report: N
CLINIDYNE ROTATIONAL PUMP
MDR report key: 2108191
·
Received May 12, 2011
Report
- Report Number
- 1313850-2011-00104
- Event Type
- Other
- Date Received
- May 12, 2011
- Date of Event
- March 3, 2011
- Report Date
- April 13, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
MATTRESSES NOT BEING RETURNED TO MANUFACTURE. RESULT: CUSTOMER INDICATED THE MATTRESSES WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT WAS BEING NURSED ON A (B)(6) MATTRESS AND ONE SIDE STOPPED FUNCTIONING, THEREFORE THEY CHANGED THE MATTRESS WITH ANOTHER CLINIDYNE. WHEN COVERS WERE UNZIPPED ON BOTH MATTRESSES IT WAS REPORTED THERE WAS BREAKTHROUGH MOISTURE UNDERNEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINIDYNE ROTATIONAL PUMP | MATTRESS | FNM | STRYKER CORP DBA GAYMAR | CLP7000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |