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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX CERAPLUS SKIN BARRIER WITH TAPE BORDER

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HOLLISTER INCORPORATED NEW IMAGE CONVEX CERAPLUS SKIN BARRIER WITH TAPE BORDER Back to Search Results
Catalog Number 11403
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review not possible because not number not known. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed.
 
Event Description
It was reported that an end user developed red itchy bumps under the tape border of the barrier. He went to the doctor who prescribed nystatin for him to apply to the area. The area has since improved.
 
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Brand NameNEW IMAGE CONVEX CERAPLUS SKIN BARRIER WITH TAPE BORDER
Type of DeviceNEW IMAGE CONVEX CERAPLUS SKIN BARRIER WITH TAPE BORDER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville IL 60048 3781
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville. 60048-3781
8476802170
MDR Report Key8130910
MDR Text Key129298053
Report Number1119193-2018-00043
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number11403
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
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 Initial

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
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