MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-07 for COLEMA BOARD W203 UNK manufactured by Unk.
[21703813]
Concerned that "alternative medicine group" is not aware or is in "denial" of latex allergies. They have included a latex tube in the kit and offer no alternative for latex allergy sufferers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014704 |
| MDR Report Key | 190769 |
| Date Received | 1998-10-07 |
| Date of Report | 1998-10-07 |
| Date Added to Maude | 1998-10-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | COLEMA BOARD |
| Generic Name | COLON CLEANING KIT |
| Product Code | KPL |
| Date Received | 1998-10-07 |
| Model Number | W203 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 185373 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-10-07 |