MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-06 for RESTORELLE - UNKNOWN manufactured by Coloplast Corp.
[183341333]
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
[183341334]
According to the available information, the patient had laparoscopic sacrocolpopexy for recurrent vaginal prolapse and a non-coloplast tvt for stress incontinence in 2016. The patient had left sided pelvic pain and pain on intercourse. Examination under anaesthesia + cystoscopy were performed to investigate the pain. The findings were 3 cms mesh extrusion into vagina, no mesh extrusion of tvt noted, and cystoscopic examination- normal. The patient was made aware and was referred to tertiary centre.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00205 |
| MDR Report Key | 9800210 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 - UNKNOWN |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST CORP |
| Manufacturer Address | 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |