MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2004-09-02 for FLEXI-TIP WITH SILICONE CUFF 865NEU manufactured by E-z-em Caribe.
[356179]
Barium enema was performed on a pt. The exam started and was completed without any indication of an adverse reaction (no pt complaints nor suspect findings on the x-ray images). The pt was sent home in the usual way. In the evening the pt felt increasing abdominal pain and went to a hosp nearby. They were treated regarding the symptoms of a peritonitis but the next morning they were sent to the ct where an extraluminal (small) deposit of contrast media was found. Although a surgical intervention was initiated immediately the pt died. The corpse was conveyed to the pathology department for an autopsy. The initial autopsy results were not available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647856-2004-00007 |
| MDR Report Key | 542482 |
| Report Source | 01,05,08 |
| Date Received | 2004-09-02 |
| Date of Report | 2004-08-04 |
| Date of Event | 2004-08-03 |
| Date Facility Aware | 2004-08-03 |
| Report Date | 2004-08-04 |
| Date Reported to Mfgr | 2004-08-04 |
| Date Mfgr Received | 2004-08-04 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2004-09-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | GINA VOGELSBERG, MGR |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | E-Z-EM CARIBE |
| Manufacturer Street | RAMAL 916 BARRIO CERRO GORDO |
| Manufacturer City | SAN LORENZO PR 00754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXI-TIP WITH SILICONE CUFF |
| Generic Name | RECTAL CATHETER W/RETENTION BALLOON |
| Product Code | FGD |
| Date Received | 2004-09-02 |
| Model Number | NA |
| Catalog Number | 865NEU |
| Lot Number | 2273865N |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 531850 |
| Manufacturer | E-Z-EM CARIBE |
| Manufacturer Address | RAMAL 916, BARRIO CERRO GORDO SAN LORENZO PR 00754 US |
| Baseline Brand Name | FLEXI-TIP WITH SILICONE CUFF |
| Baseline Generic Name | RECTAL CATHETER W/BALLOON |
| Baseline Model No | NA |
| Baseline Catalog No | 865NEU |
| Baseline ID | NA |
| Baseline Device Family | RETENTION CATHETER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 849 | 1. Death | 2004-09-02 |