MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-05 for E-Z-EM BARIUM SOLUTION PREFILLED ENEMA BAG NOT AVAILABLE * manufactured by E-z-em, Inc..
[158793]
During a water soluble barium enema, there was a perforation of the pt's colon. During a retrospective review of this incident, finalized 5/24/99, it was determined that the root cause of the perforation was a clamp on the barium enema bag that did not hold in the closed position. A letter with a copy of the medwatch form will be sent to the mfr. The radiology dept is now using two clamps on the e-z-em enema bag, to prevent any future occurrences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016891 |
| MDR Report Key | 234970 |
| Date Received | 1999-08-05 |
| Date Added to Maude | 1999-08-10 |
| 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 | RISK MANAGER |
| 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 | E-Z-EM BARIUM SOLUTION PREFILLED ENEMA BAG |
| Generic Name | ENEMA BAG CLAMP |
| Product Code | FCD |
| Date Received | 1999-08-05 |
| Model Number | NOT AVAILABLE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 227709 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 717 MAIN ST. WESTBURY NY 115905021 US |
| Baseline Brand Name | SUPER XL DELIVERY SYSTEM |
| Baseline Generic Name | EMPTY ENEMA KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 8925 |
| Baseline ID | * |
| Baseline Device Family | CS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Hospitalization | 1999-08-05 |