MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-27 for RESTORELLE - UNKNOWN manufactured by Coloplast A/s.
[186150862]
It was reported the patient also had a supris device implanted. The supris is registered under 2125050-2020-00268. (b)(4). Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[186150863]
As reported to coloplast though not verified, the patient's legal representative stated the patient suffered complications including severe pelvic pain, urinary and voiding problems, incontinence, difficulty with daily activities, suffered and continues to suffer multiple severe and painful personal injuries, including but not limited to urinary incontinence, physical deformity, and the loss of the ability to perform sexually. A revision surgery on (b)(6) 2018 was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00267 |
| MDR Report Key | 9890112 |
| Report Source | OTHER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-27 |
| 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 | STEPHANIE PERRYMAN |
| 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 - UNKNOWN |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-03-27 |
| 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. Other | 2020-03-27 |