MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-09-27 for SUPER XL DELIVERY SYSTEM 8925 manufactured by E-z-em, Inc..
[19490567]
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. The pt's condition has been stable since the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647856-1999-00040 |
| MDR Report Key | 242442 |
| Report Source | 05,06 |
| Date Received | 1999-09-27 |
| Date of Report | 1999-08-27 |
| Date of Event | 1998-10-12 |
| Date Facility Aware | 1999-05-24 |
| Report Date | 1999-08-27 |
| Date Reported to FDA | 1999-08-03 |
| Date Reported to Mfgr | 1999-08-06 |
| Date Mfgr Received | 1999-08-27 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 1999-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | PETER APRILE, RPH |
| Manufacturer Street | 717 MAIN ST. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 800544* |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER XL DELIVERY SYSTEM |
| Generic Name | EMPTY ENEMA KIT FOR AIR CONTRAST STUDIES |
| Product Code | FCD |
| Date Received | 1999-09-27 |
| Model Number | NA |
| Catalog Number | 8925 |
| Lot Number | 12498925 |
| ID Number | NA |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 227709 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | RAMAL 916, BO. CERRO GORDO SAN LORENZO PR 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 | 10 | 1999-09-27 |