MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-16 for PASTE, STOMAHESIVE * manufactured by Convatec.
[21668909]
The patient is a female with a history of anal melanoma who underwent abdomino-perineal resection three months ago. The patient was seen in the outpatient stoma clinic two months ago. The patient reported issues with leakage and achieving a seal around her stoma. The patient was utilizing a convatec medium moldable wafer. At the stoma clinic, it was advised that the patient also utilize stomahesive paste applied to the back of the wafer to improve the seal around the stoma. The patient subsequently reported an allergic reaction to the stoma adhesive with systemic complaints including exacerbation of central pain syndrome and fibromyalgia, abdominal pain, malaise, and nausea. The ostomy appliance was removed and revealed edema, inflammation, and bruising of the abdomen, stoma, and peri-stomal area. The patient reports continued "flare ups" of these symptoms, including extreme difficulty with pain, nausea, disability, and generalized malaise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2401929 |
| MDR Report Key | 2401929 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-10-26 |
| Report Date | 2011-12-16 |
| Date Reported to FDA | 2011-12-16 |
| Date Added to Maude | 2012-01-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASTE, STOMAHESIVE |
| Generic Name | STOMAHESIVE PASTE |
| Product Code | EZR |
| Date Received | 2011-12-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-16 |