MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2000-09-19 for E-Z BARIUM ENEMA TIP UNK manufactured by E-z-em, Inc..
[200110]
Case of perforation of the rectum with high morbidity from barium extravasation. The perforating involved the anterior rectal wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2000-00031 |
| MDR Report Key | 297635 |
| Report Source | 01,05 |
| Date Received | 2000-09-19 |
| Date of Report | 2000-09-18 |
| Report Date | 2000-09-18 |
| Date Reported to Mfgr | 2000-08-18 |
| Date Added to Maude | 2000-09-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETER APRILE, R PH |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-Z BARIUM ENEMA TIP |
| Generic Name | ANGLED ENEMA TIP |
| Product Code | FCD |
| Date Received | 2000-09-19 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 288093 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 750 SUMMA AVE WESTBURY NY 11590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-09-19 |