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 2018-10-11 for XENFORM SOFT TISSUE REPAIR MATRIX M0068302470 manufactured by Boston Scientific - Marlborough.
[123487341]
Alternative patient id: (b)(6). Study name: (b)(6). The complainant indicated that the device is implanted and the device is not expected to 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
[123487342]
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including cystocele repair procedure performed on (b)64) 2015. According to the complainant, the patient presented for follow-up on (b)(6) 2015 and there were no signs of infection. However, it was noted that the patient was treated for urinary tract infection on an unknown date. Her post-void residual urine volume was normal but urine was to be sent for culture to check for uti resolution. All other information is unknown. Should additional relevant details become available; a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02618 |
| MDR Report Key | 7958996 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-14 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2015-07-20 |
| Date Added to Maude | 2018-10-11 |
| 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 | 2018-10-11 |
| Model Number | M0068302470 |
| Lot Number | 0001506003 |
| Device Expiration Date | 2017-12-31 |
| 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 | 2018-10-11 |