MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-16 for FLEXI-CUFF RETENTION TIP 8816 manufactured by E-z-em Caribe.
[193669]
It was reported that, at completion of the study, the pt complained of abdominal pain and extravasation of barium was noted around the rectum. The pt was sent to the emergency room and was diagnosed with a perforated rectum. Pt was sent to the operating room and underwent a transverse loop colostomy and presacral drainage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 278159 |
| MDR Report Key | 278159 |
| Date Received | 2000-05-16 |
| Date of Report | 2000-04-14 |
| Date of Event | 2000-02-24 |
| Date Facility Aware | 2000-03-02 |
| Report Date | 2000-04-07 |
| Date Reported to Mfgr | 2000-04-14 |
| Date Added to Maude | 2000-05-19 |
| 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 | 0 |
| 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 | FLEXI-CUFF RETENTION TIP |
| Generic Name | ENEMA TIP WITH NON-LATEX CUFF |
| Product Code | FGD |
| Date Received | 2000-05-16 |
| Model Number | NA |
| Catalog Number | 8816 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 269245 |
| Manufacturer | E-Z-EM CARIBE |
| Manufacturer Address | RAMAL 916, BARRIO CERRO GORDO SAN LORENZO PR 00754 US |
| Baseline Brand Name | FLEXI-CUFF RETENTION TIP |
| Baseline Generic Name | NON LATEX ENEMA TIP |
| Baseline Model No | NA |
| Baseline Catalog No | 8816 |
| Baseline ID | NA |
| Baseline Device Family | FLEXI-TIP ENEMA TIP SERIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K905574 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-05-16 |