MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-05-26 for SALINE TESTICULAR LARGE 5206501000 manufactured by Coloplast Manufacturing Us, Llc.
[1095823]
As reported to coloplast, an item was damaged/ broken. After implant, the patient had pain and spasms the following year. Approximately two years later, the prosthesis ruptured and was removed.
Patient Sequence No: 1, Text Type: D, B5
[1196374]
As reported to coloplast, an item was damaged/ broken. After implant, the patient had pain and spasms the following year. Approximately two years later, the prosthesis ruptured and was removed.
Patient Sequence No: 1, Text Type: D, B5
[8295718]
One device was received for evaluation. Examination and testing revealed four separations between the mid line and injection port on the shell of the device. Testing revealed these to be the sites of leakage. Microscopic examination of the surfaces revealed both separations with a central groove indicating that the area was in contact with a small sharp instrument such as a needle. Because this component was released according to manufacturing and quality control procedures, coloplast concluded that the observed instrument damage on the testicular shell occurred subsequent to the device packaging being opened. This would occur when the saline is introduced into the shell through the injection port by needle when prepping the device for implant or when prepping the device for sterilization after explant. The device was returned sterilized with a butterfly needle inserted into the injection port. Because the device was implanted for 13 months, coloplast cannot determine the sequence of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[8332492]
The return of the device has been requested. It is unknown if the device is still available. 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 the device or additional information be received, an addendum to this report will be filed. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2009-00008 |
| MDR Report Key | 1392763 |
| Report Source | 05,06 |
| Date Received | 2009-05-26 |
| Date of Report | 2009-04-30 |
| Date of Event | 2009-02-01 |
| Date Mfgr Received | 2009-04-30 |
| Date Added to Maude | 2009-08-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBEKA STOLTMAN |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| 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 | SALINE TESTICULAR LARGE |
| Generic Name | TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2009-05-26 |
| Model Number | 5206501000 |
| Catalog Number | 5206501000 |
| Lot Number | 5716962-018 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | 1525 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-26 |