MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-12 for ULTRALITE OSTOMY BAG manufactured by Marlen Manufacturing.
[4714607]
I was driving home from work and had emptied my bag before i left. It was less than half full. As i was driving home i heard a popping noise and felt something wet on my legs. I then noticed that my bag had torn at the seams and stool was leaking onto my new car seats. There was a quarter size rip in the seam of the bag. I have reported this to the company on 3 occasions and reported it again today. The woman i talked to was very invalidating and said they could send a new box but then didn't ask for my name or address to file a complaint. She said she couldn't help me. This is the 8th time it has happened since the type of plastic was changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038202 |
| MDR Report Key | 4096488 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-08-26 |
| Date Added to Maude | 2014-09-18 |
| 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 | 0 |
| 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 | ULTRALITE OSTOMY BAG |
| Generic Name | OSTOMY BAG |
| Product Code | EXD |
| Date Received | 2014-09-12 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARLEN MANUFACTURING |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-12 |