MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-02 for ULTIMATE HOME COLONIC UNIT 31291 manufactured by Zygon Intl., Inc..
[17485875]
Rptr states the ad for the product has so much false info it is almost funny. She is very concerned about the harm a person could cause himself with the false info and the unit. She can only guess that the directions for use of the product are dangerous to the consumer based on the comments made in the ad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005795 |
| MDR Report Key | 21621 |
| Date Received | 1995-05-02 |
| Date Added to Maude | 1995-05-04 |
| 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 | ULTIMATE HOME COLONIC UNIT |
| Generic Name | ENEMA BUCKET |
| Product Code | FCE |
| Date Received | 1995-05-02 |
| Catalog Number | 31291 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21663 |
| Manufacturer | ZYGON INTL., INC. |
| Manufacturer Address | REDMOND WA 98052 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-05-02 |