MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-22 for DEXIDE * 210-12 manufactured by Dexide Corp..
[29246]
The pt had a pelvic tubal ligation on 10/4/96. The pt was readmitted with abdominal pain/foreign body on 11/22/96. The shaft of the penumo-needle used in the 10/4/96 surgery had broken off in the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 53186 |
| MDR Report Key | 53186 |
| Date Received | 1996-11-22 |
| Date of Report | 1996-11-22 |
| Date of Event | 1996-11-22 |
| Date Added to Maude | 1996-12-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXIDE |
| Generic Name | PNEUMO-NEEDLE #210-12 |
| Product Code | FHP |
| Date Received | 1996-11-22 |
| Model Number | * |
| Catalog Number | 210-12 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 53805 |
| Manufacturer | DEXIDE CORP. |
| Manufacturer Address | 7509 FLAGSTONE DR FORT WORTH TX 76118 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-22 |