MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2000-11-20 for SUPER XL ENEMA KIT * 8925 manufactured by E-z-em Caribe.
[19165110]
Introduction of ezem super xl enema tip into the vagina caused two vaginal lacerations which required surgical intervention. Product was disposed of. Device seemed to be smooth and not a manufacture problem. No barium was administered into the pt. Procedure was stopped before barium was administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2000-00038 |
| MDR Report Key | 305829 |
| Report Source | 05,06,07 |
| Date Received | 2000-11-20 |
| Date of Report | 2000-11-20 |
| Report Date | 2000-11-20 |
| Date Reported to FDA | 2000-08-15 |
| Date Reported to Mfgr | 2000-10-26 |
| Date Added to Maude | 2000-11-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETER APRILE, R. RH. |
| Manufacturer Street | 717 MAIN ST |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER XL ENEMA KIT |
| Generic Name | ENEMA TIP |
| Product Code | FCE |
| Date Received | 2000-11-20 |
| Model Number | * |
| Catalog Number | 8925 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 295981 |
| Manufacturer | E-Z-EM CARIBE |
| Manufacturer Address | RAMAL 916, BARRIO CERRO GORDO SAN LORENZO PR ** US |
| Baseline Brand Name | SUPER XL ENEMA KIT |
| Baseline Generic Name | ENEMA TIP |
| Baseline Model No | * |
| Baseline Catalog No | 8925 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2000-11-20 |