MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-10-21 for BIATAIN NON-ADHESIVE WOUND DRESSING 10X10 4.4MM 3341001400 manufactured by Coloplast A/s.
[1725204]
(b)(6). Product sticks to the wound. A nurse reported one sticky experience with regular, nonadhesive foam under a compression wrap. Much ingrowth and very difficult to remove (shredded in the wound).
Patient Sequence No: 1, Text Type: D, B5
[1773304]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8691724]
The device is not yet 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. Device not yet available for evaluation
Patient Sequence No: 1, Text Type: N, H10
[8872324]
The device is not yet 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. Follow-up 1. Upon testing of the returned dressing, the following tests were conducted: absorption & retention, absorption under pressure, retention capacity, thickness, and ph. All measurements conformed to specifications. A review of production & sterilization documentation yields no deviations from processes. To date, there have been no other such reports recorded for this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610694-2010-00013 |
| MDR Report Key | 1878356 |
| Report Source | 05,07 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-09-23 |
| Date Mfgr Received | 2010-09-23 |
| Date Added to Maude | 2011-01-09 |
| 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 4.4MM |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2010-10-21 |
| Model Number | 3341001400 |
| Catalog Number | 3341001400 |
| Lot Number | 2301302 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-10-21 |