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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER

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HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER Back to Search Results
Catalog Number 14902
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
Trend data reviewed and no adverse trend observed. Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review could not be conducted because the lot number is not known. Sample review not possible because no sample available. The root cause of the skin irritation cannot be determined.
 
Event Description
It was reported that an end user has been experiencing red, bumpy, irritated skin under the tape and barrier portion of the hollister ostomy appliance for the past 2 years. Six months ago she started using clobetasol propionate topical solution on the irritated areas. It clears it up but when she stops using the solution, the irritated skin returns. She has been referred to the hollister customer service group so she can trial other products.
 
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Brand NameNEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER
Type of DeviceNEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville, il
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft, va
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville., 
6802170
MDR Report Key10333348
MDR Text Key205160558
Report Number1119193-2020-00020
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 Non-Healthcare Professional
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14902
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 Received07/24/2020
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2020 Patient Sequence Number: 1
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