MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-15 for EZEM SUPER XL ENEMA BAG SYSTEM * 8925 manufactured by Ezem.
[19075642]
Introduction of ezem super xl enema tip into the vagina caused two vaginal lacerations which required surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019656 |
| MDR Report Key | 290944 |
| Date Received | 2000-08-15 |
| Date of Report | 2000-08-15 |
| Date of Event | 2000-08-09 |
| Date Added to Maude | 2000-08-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZEM SUPER XL ENEMA BAG SYSTEM |
| Generic Name | ENEMA BAG FOR RADIOLOGIC PROCEDURES |
| Product Code | FCD |
| Date Received | 2000-08-15 |
| Model Number | * |
| Catalog Number | 8925 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 281590 |
| Manufacturer | EZEM |
| Manufacturer Address | 717 MAIN WESTBURY NY 115900502 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2000-08-15 |