MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-14 for ILEOSTOMY BAG 2883 UNK manufactured by .
[679331]
Patient had ileostomy procedure done. The ileostomy bags the patient has been using do not work. The bags do not stick and feces leak everywhere in the house. Medicare does not supply enough bags and takes forever, before i can get any supplies. I desperately need some help.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003385 |
| MDR Report Key | 897114 |
| Date Received | 2007-08-14 |
| Date of Report | 2007-08-14 |
| Date Added to Maude | 2007-08-21 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILEOSTOMY BAG |
| Generic Name | NONE |
| Product Code | FON |
| Date Received | 2007-08-14 |
| Model Number | 2883 |
| Catalog Number | UNK |
| Lot Number | 15976 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 874868 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-14 |