MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-19 for MEDICAL DEVICES INTERNATIONAL * 50-750 manufactured by Medical Devices Int'l.
[224551]
When doing enema, a white slide clip/clamp slipped off end of catheter and into pt's rectum. Pt passed the item hours later. No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021395 |
| MDR Report Key | 321775 |
| Date Received | 2001-03-19 |
| Date of Report | 2001-03-19 |
| Date of Event | 2001-03-16 |
| Date Added to Maude | 2001-03-23 |
| 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 | MEDICAL DEVICES INTERNATIONAL |
| Generic Name | CLEANSING ENEMA SET |
| Product Code | FCE |
| Date Received | 2001-03-19 |
| Model Number | * |
| Catalog Number | 50-750 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 311306 |
| Manufacturer | MEDICAL DEVICES INT'L |
| Manufacturer Address | 3849 SWANSON COURT GURNEE IL 60031 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-19 |