MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-21 for EZEM 8925 manufactured by E-z-em Inc..
[626539]
Enema bag:tip balloon-purpose is to inflate in pt's rectum. In this case, 2 separate products did not inflate and were discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5001941 |
| MDR Report Key | 855193 |
| Date Received | 2007-05-21 |
| Date of Report | 2007-05-21 |
| Date of Event | 2007-05-18 |
| Date Added to Maude | 2007-06-07 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZEM |
| Generic Name | SUPER XL ENEMA SYSTEM |
| Product Code | FCD |
| Date Received | 2007-05-21 |
| Catalog Number | 8925 |
| Lot Number | 741022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 842537 |
| Manufacturer | E-Z-EM INC. |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-21 |