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 2018-10-10 for XENFORM SOFT TISSUE REPAIR MATRIX M0068302470 manufactured by Boston Scientific - Marlborough.
[123356592]
Study name: u9920 xenform a/a postmarket. 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 medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[123356593]
It was reported to boston scientific corporation that a xenform tissue repair matrix was implanted during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair procedure on (b)(6) 2014. According to the complainant, the patient experienced spontaneous rectal pain of moderate severity on the same of the procedure after she was discharged. This event was assessed as probably related to muscle spasm, and moderate in severity. She was then prescribed with diazepam, hydrocodone, dulcolax, and citrate of magnes. The patient presented for follow-up on (b)(6) 2014. On vaginal and rectal exam, the patient was tender only at the right sacrospinous ligament with pain referring down to rectal area. There were no areas of induration, no abscess, no mesh exposure or infection and no suture or graft material in rectum. Suture placement at site of sacrospinous ligament may have irritated nerve causing the pain to rectal area. On (b)(6) 2014, she underwent a surgery to release the suture and the event of rectal pain resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02616 |
| MDR Report Key | 7954493 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-10 |
| Date of Report | 2018-09-12 |
| Date of Event | 2014-04-11 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2014-02-11 |
| Date Added to Maude | 2018-10-10 |
| 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 | 2018-10-10 |
| Model Number | M0068302470 |
| Lot Number | 0001401009 |
| Device Expiration Date | 2016-10-31 |
| 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 | 2018-10-10 |