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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S MIO CLICK 50MM CVX DEEP 28 ADHESIVE / BASEPLATE

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COLOPLAST A/S MIO CLICK 50MM CVX DEEP 28 ADHESIVE / BASEPLATE Back to Search Results
Model Number 1695501400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Date 07/11/2017
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, end user had a severe allergic reaction 30-45 minutes after applying sensura mio barrier 16955 that forced her to be rushed by ambulance to her local hospital emergency room for treatment. End user was advised due to previous allergic reaction concerns to coloplast sensura to trim a sliver of the barrier and skin test first. The end user was rushed to the er in an ambulance and was released the same evening after over 3 hours. End user has a known latex allergy.
 
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Brand NameMIO CLICK 50MM CVX DEEP 28
Type of DeviceADHESIVE / BASEPLATE
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA 3050
Manufacturer (Section G)
COLOPLAST A/S THISTAD
industrivej 7, 7700 thisted
thisted,
DA
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6744660
MDR Text Key81069732
Report Number9610694-2017-00002
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1695501400
Device Catalogue Number1695501400
Device Lot Number5625811
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/26/2017 Patient Sequence Number: 1
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