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.
[87295975]
(b)(6). The complainant indicated that the device is 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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[87295976]
It was reported to boston scientific corporation that a xenform soft tissue repair matrix device was implanted during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014. According to the complainant, on (b)(6) 2015, the patient experienced a suture exposure in the anterior vagina with associated spontaneous pain. The suture exposure and the pain resolved on (b)(6) 2015 by cauterizing the granulation tissue with silver nitrate and trimming the suture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02845 |
| MDR Report Key | 6892844 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-05 |
| Date of Event | 2015-04-08 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2014-05-02 |
| 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 | 0001403009 |
| Device Expiration Date | 2017-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 |