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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT

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HOLLISTER INCORPORATED NEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT Back to Search Results
Model Number 14204
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Lot number not provided so dhr review is not possible. Sample not returned so a sample evaluation is not possible. Trend data reviewed and no adverse trend observed. End user's weight not provided so estimation used. The root cause of the skin irritation cannot be determined.
 
Event Description
It was reported that an end user developed a rash under and beyond part of the tape area of the hollister ostomy barrier. His doctor prescribed topical cream containing clortrimazole and betamethasone. The cream is wiped off before applying the barrier in order to allow the barrier and tape to adhere. The rash has not cleared up yet so he will be seeing a medical professional again.
 
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Brand NameNEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT
Type of DeviceNEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT
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, il 
3602170
MDR Report Key10272037
MDR Text Key198753028
Report Number1119193-2020-00015
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 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number14204
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 Received07/09/2020
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: 07/14/2020 Patient Sequence Number: 1
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