MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-06 for SUPER XL ENEMA BAG SYSTEM 8925 manufactured by E-z-em, Inc..
[12708]
Placement of enema tube in rectum perforated rectum. Upon extraction of the enema tip, the balloon was reinflated, demonstrating an unevenly inflated balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005028 |
| MDR Report Key | 19442 |
| Date Received | 1995-02-06 |
| Date of Report | 1995-02-01 |
| Date of Event | 1995-01-27 |
| Date Added to Maude | 1995-02-07 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 | SUPER XL ENEMA BAG SYSTEM |
| Product Code | FGD |
| Date Received | 1995-02-06 |
| Catalog Number | 8925 |
| Lot Number | 29248925 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19356 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | WESTBURY NY 11590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-02-06 |