MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-29 for ALPHA I NI manufactured by Mentor Corporation - Minnesota Div..
[463283]
According to the information there was an aneurysm.
Patient Sequence No: 1, Text Type: D, B5
[7783387]
According to the available information this inflatable penile prosthesis was revised on 05/15/2006 due to an aneurysm. One cylinder was the sole component reveived for evaluation. Examination and testing of the returned component revealed an aneurysm in the cylinder bladder. Testing revealed this to not be a site of leakage. Based on qa's examination, qa concluded that while in-vivo excess pressure may have been exerted on the cylinder bladder. Qa further concluded that this pressure, in combination with device usage, could contribute to sufficient stress (s) to aneurize the bladder at this site. No separation had occurred at this area. As qa was unable to obtain the date of implant and/or the serial number of the device, qa was unable to determine how long this device had been implanted and also unable to review the lot history of this product during the prodcution process. Management routinely reviews modes of failure, such as this. Therefore, no additional action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2006-00205 |
| MDR Report Key | 730623 |
| Report Source | 05 |
| Date Received | 2006-06-29 |
| Date of Report | 2006-06-02 |
| Date of Event | 2006-05-15 |
| Date Facility Aware | 2006-06-02 |
| Date Mfgr Received | 2006-06-02 |
| Date Added to Maude | 2006-07-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE THEISSEN |
| Manufacturer Street | * |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122874178 |
| Manufacturer G1 | MENTOR CORPORATION |
| Manufacturer Street | 1525 W RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA I |
| Generic Name | INFLATABLE PENILE PROSTHESIS |
| Product Code | FWH |
| Date Received | 2006-06-29 |
| Returned To Mfg | 2006-06-02 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 718911 |
| Manufacturer | MENTOR CORPORATION - MINNESOTA DIV. |
| Manufacturer Address | 1525 WEST RIVER RD. NORTH MINNEAPOLIS MN 55411 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-06-29 |