FDA Adverse Event
Other
Summary report: N
PMT INTEGRA TISSUE EXPANDER
MDR report key: 1706451
·
Received May 28, 2010
Report
- Report Number
- 2182979-2008-00005
- Event Type
- Other
- Date Received
- May 28, 2010
- Date of Event
- March 1, 2008
- Report Date
- May 28, 2010
- Manufacturer
- PMT CORP.
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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.
Description of Event or Problem · 1
THE HOSP CONTACTED PMT ABOUT SEVERAL EXPANDERS (ALL THE SAME SIZE) THAT HAVE LEAKED DURING SURGERY. THE DEVICES WERE EXPLANTED BUT WE WERE NOT INFORMED IF THE PROCEDURE WAS COMPLETE OR IF THE DEVICES WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMT INTEGRA TISSUE EXPANDER | TISSUE EXPANDER | FWM | PMT CORP. | 3610-10 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |