MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-27 for ALPHA I NI manufactured by Mentor Corporation - Minnesota Divisi.
[418657]
According to the information the tubing to the reservoir was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2005-00267 |
| MDR Report Key | 622803 |
| Report Source | 05 |
| Date Received | 2005-07-27 |
| Date of Report | 2005-06-27 |
| Date of Event | 2005-06-14 |
| Date Facility Aware | 2005-06-27 |
| Date Mfgr Received | 2005-06-27 |
| Date Added to Maude | 2005-07-28 |
| 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 | 1525 WEST RIVER ROAD NORTH |
| 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 | 2005-07-27 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 612450 |
| Manufacturer | MENTOR CORPORATION - MINNESOTA DIVISI |
| Manufacturer Address | 1525 WEST RIVER RD. NORTH MINNEAPOLIS MN 55411 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-07-27 |