MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-26 for PELVIC DISPLACEMENT PROSTHESIS * manufactured by Bioenterics Corp..
[202220]
Add'l info rec'd from rptr 2/2/01: title of project: radioprotection of small intestine during therapy for locally advanced cervical cancer utilizing a pelvic displacement prosthesis placed at the time of laparoscopic staging.
Patient Sequence No: 1, Text Type: D, B5
[215124]
During insertion of pelvic displacement prosthesis device ruptured secondary to using graspers for fraction. Bag removed prior to final placement. No untoward event to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020931 |
| MDR Report Key | 313969 |
| Date Received | 2001-01-26 |
| Date of Report | 2001-01-23 |
| Date of Event | 2001-01-05 |
| Date Added to Maude | 2001-01-31 |
| 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 | 0 |
| 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 | PELVIC DISPLACEMENT PROSTHESIS |
| Generic Name | SILICON IMPLANT |
| Product Code | MIB |
| Date Received | 2001-01-26 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 303652 |
| Manufacturer | BIOENTERICS CORP. |
| Manufacturer Address | 1035 A CINDY LANE CARPENTERIA CA 93013 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-01-26 |