MAUDE Adverse Event Report: COLOPLAST A/S MIO FLEX 50MM 10-48; ADHESIVE/BASEPLATE

Model Number 1056101032

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

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 information received, patient and nurse state that the baseplate adheres to small skin area so hard that the skin is ripped off.The adhesion is "normal" on other areas and this small area where adhesion is hard is of a size of a top op a finger.This area also varies in different places under the baseplate, so it is not the same place every time.

• Brand Name: MIO FLEX 50MM 10-48
• Type of Device: ADHESIVE/BASEPLATE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S THISTED; industrivej 7, 7700; thisted, 7700 ; DA 7700
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5432257
• MDR Text Key: 38603177
• Report Number: 9610694-2016-00004
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/11/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1056101032
• Device Catalogue Number: 1056101032
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other