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 2018-08-15 for XENFORM SOFT TISSUE REPAIR MATRIX M0068302470 manufactured by Boston Scientific - Marlborough.
[117167482]
The patient? S id is (b)(6). Study name: (b)(6). The complainant indicated that the device will not be returned for investigation. 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
[117167483]
It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor reconstruction with apical vault suspension and cystocele repair procedure performed on (b)(6) 2015. According to the complainant, on (b)(6) 2015, the patient experienced a lower urinary tract infection and was treated with augmentin. The event was resolved on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02560 |
| MDR Report Key | 7785092 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-15 |
| Date of Report | 2018-07-20 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2014-12-23 |
| Date Added to Maude | 2018-08-15 |
| 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 | 2018-08-15 |
| Model Number | M0068302470 |
| Lot Number | 0001411010 |
| Device Expiration Date | 2017-09-30 |
| 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 | 2018-08-15 |