MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-25 for XENFORM SOFT TISSUE REPAIR MATRIX M0068302470 manufactured by Boston Scientific - Marlborough.
[87294101]
(b)(6). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[87294102]
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform procedure performed on (b)(6) 2014. According to the complainant, on (b)(6) 2017, the patient experienced dyspareunia. She was treated with physical therapy and the event has not yet resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02839 |
| MDR Report Key | 6892552 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-09-01 |
| Device Manufacturer Date | 2014-06-03 |
| Date Added to Maude | 2017-09-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | TEI BIOSCIENCES INCORPORATED |
| Manufacturer Street | 7 ELKINS STREET |
| Manufacturer City | BOSTON MA 02127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENFORM SOFT TISSUE REPAIR MATRIX |
| Generic Name | MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO |
| Product Code | PAJ |
| Date Received | 2017-09-25 |
| Model Number | M0068302470 |
| Lot Number | 0001404014 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-25 |