FDA Adverse Event
Other
Summary report: N
PMT INTEGRA TISSUE EXPANDER
MDR report key: 1706448
·
Received May 28, 2010
Report
- Report Number
- 2182979-2008-00002
- Event Type
- Other
- Date Received
- May 28, 2010
- Report Date
- May 28, 2010
- Manufacturer
- PMT CORP.
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING INITIATED FOLLOWING AN FDA FIELD AUDIT, RECOMMENDING A COMPLETE REVIEW OF PAST COMPLAINTS. THIS FILING IS A RESULT OF THAT REVIEW. AN EVAL OF THE DEVICE WAS PERFORMED ON (B)(6) 2009. THE INVESTIGATION FOUND SEVERAL HOLES AROUND THE TISSUE EXPANDER PORT CAUSED BY A NEEDLE OR OTHER SHARP INSTRUMENT. THE PIN HOLES WERE THE CAUSE OF THE MALFUNCTION. THE PIN HOLES COULD ONLY HAVE BEEN CAUSED DURING MISHANDLING AT THE USER FACILITY, NOT IN MFG.
Description of Event or Problem · 1
THE HOSP CONTACTED PMT TO REPORT LEAKS IN THE EXPANDER. WE HAVE NOT CONFIRMED IF THE TISSUE EXPANDER WAS REPLACED OR IF THE TREATMENT WAS NOT COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMT INTEGRA TISSUE EXPANDER | TISSUE EXPANDER | FWM | PMT CORP. | 3611ES-204-2I | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |