MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for SUPER XL ENEMA SYSTEM 901203 manufactured by E-z-em, Inc. (bracco Diagnostics).
[78816510]
The following elements have blank data
Patient Sequence No: 1, Text Type: N, H10
[78816511]
The balloon on the enema tips are deflating. This has happened on at least 4 recent patients. While performing an enema on multiple patients, the balloon that keeps the tip in place slowly deflates. During one exam we had to reinsert the tip so the exam could be completed. Sister hospital indicated that they were having similar issues with this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6680242 |
| MDR Report Key | 6680242 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-05-31 |
| Report Date | 2017-06-27 |
| Date Reported to FDA | 2017-06-27 |
| Date Reported to Mfgr | 2017-06-27 |
| Date Added to Maude | 2017-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 ENEMA SYSTEM |
| Generic Name | BARIUM ENEMA CATHETER |
| Product Code | FGD |
| Date Received | 2017-06-30 |
| Model Number | 901203 |
| Catalog Number | 901203 |
| Lot Number | 60051579 |
| ID Number | 1303671G |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM, INC. (BRACCO DIAGNOSTICS) |
| Manufacturer Address | 155 PINELAWN RD. MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-30 |