FDA Adverse Event
Injury
Summary report: N
XENFORM SOFT TISSUE REPAIR MATRIX
MDR report key: 4745295
·
Received May 4, 2015
Report
- Report Number
- 3005099803-2015-01063
- Event Type
- Injury
- Date Received
- May 4, 2015
- Report Date
- April 8, 2015
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- PAJ
- PMA / PMN Number
- K060984
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED LOT NUMBER, 0802016, COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN AT THIS TIME.
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 |
|---|---|---|---|---|---|---|---|
| 291346 | XENFORM SOFT TISSUE REPAIR MATRIX | MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO | PAJ | BOSTON SCIENTIFIC - MARLBOROUGH | M0068302470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |