MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-12-16 for BIATAIN SUPER, ADH 10X10 0461001006 manufactured by Coloplast A/s.
[33718946]
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 additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[33718947]
According to the information received, product delamination, also skin blistered under dressing. We were treating both pressure sores with honey as a primary and biatain as a secondary dressing which was managing the exudate well. His skin came off when i removed the dressing on his left foot and the centre of the dressing had stuck to his skin and had come away from the top layer. He must have blistered beneath the dressing. The blistered areas have now healed well and we have not applied an adhesive material to his legs since. Treatment was with a non-adherent wound contact layer and absorbent pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610694-2015-00001 |
| MDR Report Key | 5305180 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-16 |
| Date Mfgr Received | 2015-11-20 |
| Date Added to Maude | 2015-12-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE BUCKVOLD |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024982 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | HOLTEDAM 1 |
| Manufacturer City | HUMLEBAEK, DA 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 SUPER, ADH 10X10 |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2015-12-16 |
| Model Number | 0461001006 |
| Catalog Number | 0461001006 |
| 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, DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Other | 2015-12-16 |