MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-26 for * manufactured by Unk.
[15614966]
Dr used "small stainless steel donuts", which their spouse made at home, to secure a spliting tube in a 03/2003 surgery. Two months later the pt had to have another surgery to remove these stainless steel devices. Four months later the quality/risk management director became aware that the devices were used and that they were not obtained through the hospital's normal vendor supplier procedure and that the doctor did not seek approval of manufactured devices through medical staff and administrative/risk management. Hospital contacted dept of health who determined that the hospital took appropriate action upon learning of the devices used and instructed hospital to let fda know of the doctor's practices in case of future device manufacturing practices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003726 |
| MDR Report Key | 526391 |
| Date Received | 2004-03-26 |
| Date of Report | 2004-03-26 |
| Date of Event | 2003-05-01 |
| Date Added to Maude | 2004-05-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | SMALL STAINLESS STEEL DONUT |
| Product Code | LNN |
| Date Received | 2004-03-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 515552 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-26 |