FDA Adverse Event
Other
Summary report: N
PMT INTEGRA TISSUE EXPANDER
MDR report key: 1706452
·
Received May 28, 2010
Report
- Report Number
- 2182979-2008-00006
- Event Type
- Other
- Date Received
- May 28, 2010
- Date of Event
- February 1, 2008
- Report Date
- May 28, 2010
- Manufacturer
- PMT CORP.
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
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 HOSPITAL CONTACTED PMT ON (B)(6) 2008, TO REPORT THAT A TISSUE EXPANDER LEAKED DURING SURGERY. THE EXPANDER WAS REMOVED BUT WE DO NOT KNOW IF IT WAS REPLACED OR IF THE PROCEDURE WAS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMT INTEGRA TISSUE EXPANDER | TISSUE EXPANDER | FWM | PMT CORP. | 3610ES-76 | 121406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |