MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-03 for GENESIS KIT 11 COATED 5192601400 519260 manufactured by Coloplast A/s.
[177671710]
Two malleable rods were received for evaluation. As examination of the device may not conclusively confirm or disprove the report of infection quality accepts the physician's observations as to the reason for surgical intervention. The review of the device lot history records indicates this lot passed sterility testing prior to being released. The device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the device. A review of the device history record confirmed the devices from this lot met all specifications prior to release. A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
Patient Sequence No: 1, Text Type: N, H10
[177671711]
According to the available information, the device was explanted and replaced due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00093 |
| MDR Report Key | 9662283 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-05 |
| Date Mfgr Received | 2020-01-05 |
| Date Added to Maude | 2020-02-03 |
| 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 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 | GENESIS KIT 11 COATED |
| Generic Name | PENILE PROSTHESIS |
| Product Code | FAE |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2020-01-09 |
| Model Number | 5192601400 |
| Catalog Number | 519260 |
| Lot Number | 6837748 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-02-03 |