FDA Adverse Event
Malfunction
Summary report: N
TEMP PUMP PROFESSIONAL
MDR report key: 2112682
·
Received April 29, 2011
Report
- Report Number
- 1313850-2011-00091
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- ILO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REC'D BY MFR IN DAMAGED CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT'S HOUSING WAS DAMAGED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMP PUMP PROFESSIONAL | PUMP | ILO | STRYKER CORP DBA GAYMAR | TP700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |