FDA Adverse Event
Injury
Summary report: N
EXAIR ANTERIOR
MDR report key: 5047944
·
Received September 1, 2015
Report
- Report Number
- 2125050-2015-00088
- Event Type
- Injury
- Date Received
- September 1, 2015
- Date of Event
- July 6, 2012
- Report Date
- June 16, 2015
- Manufacturer
- COLOPLAST CORP
- Product Code
- OTP
- PMA / PMN Number
- K112386
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. RESPONSE MADE BECAUSE DEVICE WAS NOT RETURNED. (B)(4).
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH EXAIR ANTERIOR MESH. LATER THE PATIENT EXPERIENCED INCONTINENCE, PAIN, DYSPAREUNIA AND DRYNESS. THE PATIENT WAS IMPLANTED WITH A COMPETITOR'S PRODUCT AND A REVISION OF THE EXISTING MESH WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578078 | EXAIR ANTERIOR | SURGICAL MESH | OTP | COLOPLAST CORP | 2382591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R |