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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER

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HOLLISTER INCROPORATED NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER Back to Search Results
Catalog Number 14603
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 03/30/2022
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Lot number not provided so device history records could not be reviewed. Sample not returned so sample evaluation not possible. End user has a history of reactions to other medical products and contrast media. Root cause of reported reaction to the ostomy appliance cannot be determined.
 
Event Description
It was reported that an end user developed a skin reaction to the hollister new image ostomy barrier shortly after she started using it after stoma surgery. She reported she was hospitalized for the reaction and given steroids. She stated that once she was discharged and stopped the steroids, she started to develop the skin reaction again while she continued to use the hollister new image ostomy barrier. She reported that she saw a dermatologist who placed her on dupixent injections, which did not help her skin reaction. She also reported that she has tried other ostomy appliance manufacturer's products which also caused skin reactions.
 
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Brand NameNEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Type of DeviceNEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Manufacturer (Section D)
HOLLISTER INCROPORATED
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, IL 60048-3781
8476802170
MDR Report Key14428721
MDR Text Key291936263
Report Number1119193-2022-00015
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 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14603
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2022
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 Unkown

Patient Treatment Data
Date Received: 05/18/2022 Patient Sequence Number: 1
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