FDA Adverse Event
Injury
Summary report: N
XENFORM SOFT TISSUE REPAIR MATRIX
MDR report key: 4232667
·
Received November 6, 2014
Report
- Report Number
- 3005099803-2014-03487
- Event Type
- Injury
- Date Received
- November 6, 2014
- Report Date
- October 17, 2014
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- PAJ
- PMA / PMN Number
- K060984
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
IT IS UNKNOWN WHICH DATE THE DEVICE WAS IMPLANTED: (B)(6) 2011 OR (B)(6) 2013.
Description of Event or Problem · 1
AS REPORTED BY THE PATIENT¿S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN AND DISABILITY. 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 |
|---|---|---|---|---|---|---|---|
| 712595 | XENFORM SOFT TISSUE REPAIR MATRIX | MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO | PAJ | BOSTON SCIENTIFIC - MARLBOROUGH | M0068302450 | 0001009029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |