MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for SUPER XL EMPTY ENEMA KIT 8925 manufactured by E-z-em, Inc..
[80925658]
Patient Sequence No: 1, Text Type: N, H10
[80925659]
The retention cuff was tested prior to inserting the tip of the enema system. The tip was inserted; the cuff was inflated and clamped off. During the procedure, the cuff failed, and barium leaked out all over the patient and the x-ray table. We had to cut the enema tip off the tubing and use a new enema system. The patient had to get off the table, get washed off and the bed had to be changed. We were then able to complete the exam. Manufacturer response for enema system, e-z-em (per site reporter). The manufacturer hasn't yet had an opportunity to evaluate the defective produce.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6740151 |
| MDR Report Key | 6740151 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-28 |
| Report Date | 2017-06-30 |
| Date Reported to FDA | 2017-06-30 |
| Date Reported to Mfgr | 2017-06-30 |
| Date Added to Maude | 2017-07-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | SUPER XL EMPTY ENEMA KIT |
| Generic Name | CATHETER, RETENTION, BARIUM ENEMA WITH BAG |
| Product Code | FGD |
| Date Received | 2017-07-25 |
| Returned To Mfg | 2017-06-30 |
| Catalog Number | 8925 |
| Lot Number | 60054125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 155 PINELAWN RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |