MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-30 for SUR-FIT NATURA DH SKIN BARRIER W/CONVEX-IT 413177 manufactured by Convatec.
[379305]
Dermatologists called to request ingredients for the durahesive and tape collar portion of the wafer. Customer, who had been using product for an "extended period" began having a rash under the entire portion of the wafer in 2003. Dermatologists did patch testing, 8 months later, and patient had reaction within 24 hours with redness under entire wafer. Customer was advised to avoid any scented products and to use zinc oxide over the rash to dry the area and to take atarax to relieve itching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00028 |
| MDR Report Key | 597442 |
| Report Source | 05 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 2003-03-01 |
| Date Mfgr Received | 2003-11-11 |
| 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 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA DH SKIN BARRIER W/CONVEX-IT |
| Generic Name | OSTOMY APPLIANCE |
| Product Code | EZS |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 413177 |
| Lot Number | UNK |
| 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 | 587270 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT NATURA DURAHESIVE SKIN BARRIER WITH CONVEX IT |
| Baseline Generic Name | SKIN BARRIER |
| Baseline Catalog No | 413177 |
| 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. Other | 2005-04-30 |