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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED DUOLOCK TAIL CLSR CURVED TAN; APPLIANCE, COLOSTOMY, DISPOSABLE
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CONVATEC LIMITED DUOLOCK TAIL CLSR CURVED TAN; APPLIANCE, COLOSTOMY, DISPOSABLE Back to Search Results
Model Number SRA8280
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Discomfort (2330)
Event Type  malfunction  
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.
 
Event Description
It was reported by the end user that the tail clips dig and irritate her flesh in the area of the abdomen where the clip rests/digs in.It was also reported that this has occurred with other similar products for years.
 
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Brand Name
DUOLOCK TAIL CLSR CURVED TAN
Type of Device
APPLIANCE, COLOSTOMY, DISPOSABLE
Manufacturer (Section D)
CONVATEC LIMITED
first avenue
deeside industrical park
deeside, flinshire CH52N U
UK  CH52NU
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key5527133
MDR Text Key41548607
Report Number1000317571-2016-00032
Device Sequence Number1
Product Code EZS
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSRA8280
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/02/2016
Initial Date FDA Received03/25/2016
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 Unknown
Patient Sequence Number1
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