MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-16 for RESTORELLE manufactured by Coloplast A/s.
[175428108]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[175428109]
According to the available information, soon after the patient had an abdominal wall hernia repair, she retuned to the doctor with acute pain and concern about protrusion. She was told that it was just scar tissue, and nothing to worry about. Over the coming years she experienced ongoing pain, and a series of increasingly severe problems including fatigue, auto-immune diseases, hormonal issues, urinary incontinence, sexual dysfunctional, all of which impacted my life. None of these existed prior to this procedure. She reported she had seen a number of doctors, specialists, took a number of tests, none of which helped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00044 |
| MDR Report Key | 9598222 |
| Report Source | OTHER |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-13 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-16 |
| 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 | 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 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6124345685 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORELLE |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-01-16 |
| 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 | 2020-01-16 |