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 2020-03-19 for RESTORELLE Y manufactured by Coloplast A/s.
[184167190]
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
[184167191]
According to the available information, the patient had surgery for bladder prolapse with restorelle y. After less than three months, the mesh had stretched. It was reported that the patient's new surgeon knew how to remove it and replace it and also repair the scarring. The patient was experiencing severe pain so the mesh was explanted. A non-coloplast mesh was implanted. The surgery and recovery were painful. The patient is no longer experiencing pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00256 |
| MDR Report Key | 9856189 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-19 |
| 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 | LAUREN PRIOLEAU |
| 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 | 2020-03-19 |
| 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. Required No Informationntervention | 2020-03-19 |