MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-05 for VIRTUE MALE SLING SYSTEM 5002041022 500204 manufactured by Coloplast A/s.
[188057661]
The lot number was reviewed for complaint trend, nonconforming report and capa review. Devices met specification prior to release and no trends were noted. 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
[188057662]
According to the available information, a (b)(6) year old patient experienced perineal hematoma after virtue procedure. Date of surgery: (b)(6) 2020, date of onset event: (b)(6) 2020, description of the event: perineal hematoma with pain occurred 2 days after the catheter removal. Treatment: ibuprofen and paracetamol status of the event: resolved on (b)(6) 2020. According to the investigator, this event is related to procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00193 |
| MDR Report Key | 9793755 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-05 |
| 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 | VIRTUE MALE SLING SYSTEM |
| Generic Name | SURGICAL MESH |
| Product Code | OTM |
| Date Received | 2020-03-05 |
| Model Number | 5002041022 |
| Catalog Number | 500204 |
| Lot Number | 6949467 |
| 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 | 2020-03-05 |