MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-06 for RESTORELLE Y 5014202400 501420 manufactured by Coloplast A/s.
[182470471]
(b)(4). The lot number was reviewed for complaint trend, nonconforming report and capa. Devices met specification prior to release and no trends were noted. Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[182470472]
As reported to coloplast though not verified, patient's legal representative stated severe pain with daily activities, painful intercourse, vaginal discharge, atrophy of the vagina and incontinence of feces. Plaintiff has suffered and continues to suffer multiple severe and painful personal injuries, including but not limited to, vaginal prolapse, urinary incontinence, physical deformity an the loss of the ability to perform sexually. A portion of the device was removed due to multiple areas of mesh erosion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00216 |
| MDR Report Key | 9802690 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH O'GARA |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORELLE Y |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-03-06 |
| Model Number | 5014202400 |
| Catalog Number | 501420 |
| Lot Number | 3812399 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-06 |