MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for SUPER XL ENEMA SYSTEM manufactured by E-z Em Inc / Bracco Diagnostics.
[80768080]
Reported to risk that radiology was performing a test and using the barium enema bag on a pt when the balloon mechanism leaked. This required the enema bag system to have to be replaced and repeated instillation of barium. This is not the first report to the company of this type of situation with the super xl enema system. A med-watch was completed back in (b)(6) with the same situation but a different lot number is involved. This device was not saved but there was one more enema bag system to this lot number in stock and was pulled from stock and sequestered by risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071126 |
| MDR Report Key | 6732264 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-09 |
| Date of Event | 2017-06-29 |
| Date Added to Maude | 2017-07-21 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPER XL ENEMA SYSTEM |
| Generic Name | ENEMA BAG |
| Product Code | FCE |
| Date Received | 2017-07-20 |
| Lot Number | 60024486 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z EM INC / BRACCO DIAGNOSTICS |
| Manufacturer Address | 259 PROSPECT PLAINS ROAD MONROE TOWNSHIP NJ 08831 US 08831 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-20 |