MAUDE Adverse Event Report: COLOPLAST A/S BIATAIN SOFT-HOLD 15X15 4.4MM; DRESSING,WOUND,OCCLUSIVE

Model Number 3347501008

Device Problems Occlusion Within Device (1423); Device-Device Incompatibility (2919)

Patient Problem Fluid Discharge (2686)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

According to the available information, biatain soft-hold was used as primary dressing over a fluid skin patch.Biatain soft-hold was fixed with an unnamed film bandage throughout the dressing.The skin patch had been damaged, and it is suspected that it was due to the combination of the film bandage and biatain soft-hold, which therefore became too occlusive.It was a breast surgery with lap reconstruction.The film bandage that was used is from smith & nephew.Exudate was present, and the lab was lost.The lab was fixated with biatain soft-hold over the whole topfilm with opsite from s&n.The ifu states that biatain soft-hold has to be covered by a secondary dressing.There is now caution about permeability or which secondary dressing is recommended.

• Brand Name: BIATAIN SOFT-HOLD 15X15 4.4MM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S NYIRBATOR; coloplast utca 2; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: michael bumgarner ; 1601 west river road north; minneapolis, MN 55411
• MDR Report Key: 7370783
• MDR Text Key: 103474908
• Report Number: 3006606901-2018-00010
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: K983173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3347501008
• Device Catalogue Number: 3347501008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other