MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-10-20 for BIATAIN NON-ADHESIVE WOUND DRESSING 10X10 0341001004 manufactured by Coloplast A/s.
[2285635]
Skin irritation; the dermatologist reported contact eczema with ulcerations repeatedly in 2010 & 2011. A patch test with biatain foam was positive. The product was discontinued but the skin reaction is not healed.
Patient Sequence No: 1, Text Type: D, B5
[9314978]
The device is not available for evaluation. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should the device or additional information be received, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610694-2011-00004 |
| MDR Report Key | 2302949 |
| Report Source | 01,05 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-09-23 |
| Date Mfgr Received | 2011-09-23 |
| Date Added to Maude | 2011-10-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBEKA STOLTMAN -- RA MANAGER |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | HOLTEDAM-1 |
| Manufacturer City | HUMLEBAEK, 3050 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 3050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIATAIN NON-ADHESIVE WOUND DRESSING 10X10 |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2011-10-20 |
| Model Number | 0341001004 |
| Catalog Number | 0341001004 |
| Lot Number | 2501345 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM-1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-20 |