MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-16 for XENFORM M0068302470 830-247 manufactured by Boston Scientific Corporation.
[186615777]
(b)(4). The complaint 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
[186615778]
It was reported to boston scientific corporation that the patient had recurrent cystocele and recurrent vaginal vault prolapse. She was implanted with a xenform device during a procedure for sacrospinous ligament fixation, with concomitant revision of a previously-implanted non-bsc mesh device. As reported by the patient's attorney, on (b)(6) 2015, the patient underwent a procedure for cystocele repair with native tissue due to recurrent cystocele, recurrent infections, and incomplete bladder emptying. Boston scientific has been unable to obtain additional information regarding the event to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01042 |
| MDR Report Key | 9834501 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2014-05-21 |
| Date Added to Maude | 2020-03-16 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | INTEGRA LIFE SCIENCES SALES LLC |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENFORM |
| Generic Name | MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO |
| Product Code | FTM |
| Date Received | 2020-03-16 |
| Model Number | M0068302470 |
| Catalog Number | 830-247 |
| 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 CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |