FDA Adverse Event
Injury
Summary report: N
XENFORM SOFT TISSUE REPAIR MATRIX
MDR report key: 4915300
·
Received July 15, 2015
Report
- Report Number
- 3005099803-2015-01946
- Event Type
- Injury
- Date Received
- July 15, 2015
- Report Date
- June 29, 2015
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- PAJ
- PMA / PMN Number
- K060984
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SECOND PHYSICIAN WAS REPORTED WITH THIS EVENT; BOTH PHYSICIANS IMPLANTED THE XENFORM® SOFT TISSUE REPAIR MATRICES: (B)(6).
Description of Event or Problem · 1
AS REPORTED BY THE PATIENT¿S ATTORNEY, TWO XENFORM® SOFT TISSUE REPAIR MATRICES (MFR REPORT #3005099803-2015-01945 AND MFR REPORT #3005099803-2015-01946) WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458743 | XENFORM SOFT TISSUE REPAIR MATRIX | MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO | PAJ | BOSTON SCIENTIFIC - MARLBOROUGH | UNK166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |