MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-02 for SALINE TEST INT MEDIUM 5207301000 manufactured by Coloplast A/s.
[51769790]
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 of 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
[51769791]
According to the available information, product contains a leak/hole. The patient had a revision surgery because of the leak and it was not replaced with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2016-00095 |
| MDR Report Key | 5841178 |
| Date Received | 2016-08-02 |
| Date of Report | 2016-08-02 |
| Date of Event | 2016-06-13 |
| Date Mfgr Received | 2016-07-05 |
| Date Added to Maude | 2016-08-02 |
| 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 | CHRISTINE BUCKVOLD |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024982 |
| 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 | 0 |
| Brand Name | SALINE TEST INT MEDIUM |
| Generic Name | SALINE FILLED TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2016-08-02 |
| Returned To Mfg | 2016-07-05 |
| Model Number | 5207301000 |
| Catalog Number | 5207301000 |
| Operator | PHYSICIAN |
| 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, DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-02 |