MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-19 for RESTORELLE Y CONTOUR manufactured by Coloplast A/s.
[167055085]
The device has been received at coloplast; however the evaluation is not yet complete. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Once our evaluation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[167055086]
According to the available information, the patient experienced reoccurrence of prolapse about one year after surgery. It was reported there was no device malfunction. The device was explanted and was damaged (cut at sacral tail) to facilitate explant. The device was not replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2019-01027 |
| MDR Report Key | 9343990 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2019-10-09 |
| Date Added to Maude | 2019-11-19 |
| 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 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122196218 |
| 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 Y CONTOUR |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2019-11-19 |
| Returned To Mfg | 2019-11-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-19 |