FDA Adverse Event
Other
Summary report: N
PMT INTEGRA TISSUE EXPANDER
MDR report key: 1706467
·
Received May 28, 2010
Report
- Report Number
- 2182979-2009-00015
- Event Type
- Other
- Date Received
- May 28, 2010
- Date of Event
- May 8, 2009
- Report Date
- May 28, 2010
- Manufacturer
- PMT CORPORATION
- Product Code
- LCJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT # 123008. 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 CUSTOMER INFORMED PMT OF A LEAK NEAR THE INTERNAL PORT WITH ONE EXPANDER. THE PHYSICIAN EXPLANTED BOTH EXPANDERS, BUT ONLY ONE WAS REPORTED LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMT INTEGRA TISSUE EXPANDER | TISSUE EXPANDER | LCJ | PMT CORPORATION | 3611-31I | 122308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |