MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-04-30 for I1E-SORB ABSORBENT GEL PACK 400478 manufactured by Convatec.
[17762431]
In 1998 customer called with concerns of "ulcers" on stoma mucosa for 3 days. At time of event customer was using the following products; nu-hope skin barrier strips (item #4068), hollister skin barrier (item #7805), nu-hope 1 piece convex drainable appliance (item #40-7211-c), stomahesive paster, and i1e-sorb packets. Patient had been using all products for about one year except the hollister skin barrier, which customer had been using for approximatily 6 months. Stoma was medium to dark red in color, shiny in appearance with multiple (at least 12) shallow to deep "ulcers" on the inside and outside of the stoma. Peristomal skin was clear and intact. Called doctor to report that customer passed some blood (clot-like) from the stoma and that there was another clot on the stoma. Patient went to er where the physician removed the clot from the stoma and added two sutures. The physician noticed multiple ulcers on the stoma. Et reported that md believes that stomal ulcers may have been caused by systemic condition. Rn does not believe that stomal ulcers are related to product use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00013 |
| MDR Report Key | 597623 |
| Report Source | 04 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 2000-06-29 |
| Date Added to Maude | 2005-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9099042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I1E-SORB ABSORBENT GEL PACK |
| Generic Name | OSTOMY ACCESSORY |
| Product Code | EZR |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 400478 |
| Lot Number | USC-564 |
| ID Number | * |
| Device Expiration Date | 2004-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 587453 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | I1E-SORB ABSORBENT GEL PACK |
| Baseline Generic Name | OSTOMY ACCESSORY |
| Baseline Model No | NA |
| Baseline Catalog No | 400478 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-30 |