MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for HASSON BUEC - 3 SILICONE BALLOON 110111 manufactured by Weck, Inc..
[17765056]
During a laparoscopic procedure, the device was inflated and burst.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30798 |
| MDR Report Key | 30798 |
| Date Received | 1996-01-18 |
| Date of Report | 1996-01-15 |
| Date Added to Maude | 1996-03-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HASSON BUEC - 3 SILICONE BALLOON |
| Generic Name | UTERINE ELEVATOR CANNULA - 3 |
| Product Code | HDP |
| Date Received | 1996-01-18 |
| Catalog Number | 110111 |
| Lot Number | 5101178 |
| Operator | OTHER |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31855 |
| Manufacturer | WECK, INC. |
| Manufacturer Address | 5645 N RAVENWOOD AVE CHICAGO IL 60660 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-01-18 |