MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-03-22 for SUR-FIT NATURA DH SKIN BARRIER WITH CONVEX IT * 413181 manufactured by Convatec.
[376743]
Comsumer had had two episodes of gram negative septicemia with abdominal wall cellulitis (infection) requiring hospitalization for intravenous antibiotics in the past 9 months. The second episode happened in march. Consumer had changed their wafer 413181 the day before, consumer woke up with mid left sided abdominal pain and within one hour there was marked redness, swelling under the bottom half of their skin barrier and off to the left side of their abdomen. The abdominal pain also became pregoressively worse. Consumer was hospitalized, treated and released. The skin on thier abdomen is nearly back to normal and there is only slight redness noted. Consumer has been in contact with their et nurse who has made several suggestions. They will now always use an adhesive remover when removing their skin barrier. They will also try skin protector wipes to add an extra layer of protection to reduce chances of skin stripping. The et has asked consumer to use eakin seals to give more protection to the skin at the base of the stoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00009 |
| MDR Report Key | 584677 |
| Report Source | 04 |
| Date Received | 2005-03-22 |
| Date of Report | 2005-03-22 |
| Date of Event | 2005-03-15 |
| Date Mfgr Received | 2005-03-15 |
| Date Added to Maude | 2005-03-25 |
| 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 DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA DH SKIN BARRIER WITH CONVEX IT |
| Generic Name | DURAHESIVE SKIN BARRIER |
| Product Code | EZS |
| Date Received | 2005-03-22 |
| Model Number | * |
| Catalog Number | 413181 |
| Lot Number | * |
| ID Number | * |
| 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 | 574509 |
| Manufacturer | CONVATEC |
| Manufacturer Address | * SKILLMAN NJ * US |
| Baseline Brand Name | SUR-FIT NATURA DURAHESIVE SKIN BARRIER WITH CONVEX IT |
| Baseline Generic Name | SKIN BARRIER |
| Baseline Catalog No | 413181 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-03-22 |