MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-14 for MILLER ENEMA AIR TIP * 8816 manufactured by Ezem Incorp.
[539791]
Pt was simulated for pelvic xrt w/rectal balloon. Balloon was inflated but did not hold through ct scan. Wasn't noticed until dr went to draw contours for plan. Therefore dr ordered new ct scan to be performed again with new rectal balloon delaying pt's treatment. Per staff, question if defect was in balloon or glue where tip attaches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040171 |
| MDR Report Key | 755170 |
| Date Received | 2005-10-14 |
| Date of Report | 2005-10-14 |
| Date of Event | 2005-09-26 |
| Date Added to Maude | 2006-08-30 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLER ENEMA AIR TIP |
| Generic Name | RECTAL BALLOON |
| Product Code | FGD |
| Date Received | 2005-10-14 |
| Model Number | * |
| Catalog Number | 8816 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 742991 |
| Manufacturer | EZEM INCORP |
| Manufacturer Address | 1111 MARCUS AVE STE LL-26 LAKE SUCCESS NY 11042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-14 |