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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 OSTOMY BARRIER

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HOLLISTER INCROPORATED NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER Back to Search Results
Catalog Number 14604
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 05/15/2022
Event Type  Injury  
Event Description
It was reported that an end user, who had been using hollister ostomy products for the last 10 years, started experiencing skin irritation under the ostomy barrier last month. She reported that her skin was red and warm to touch. She reported that she went to the ed who told her it was contact dermatitis. She reported that the ed gave her a pain shot, and antibiotics shot. She also reported she was sent home with a prescription for antibiotics and ascend silver sulfadiazine 1% cream for her irritated skin. End user reported that her skin has since improved but not completely. End user will trial other hollister ostomy products to see if that works better for her.
 
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. Root cause of reported contact dermatitis to the barrier of the ostomy appliance cannot be determined.
 
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Brand NameNEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER
Type of DeviceNEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY 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 Key14755645
MDR Text Key294405423
Report Number1119193-2022-00020
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 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14604
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/10/2022
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 Initial

Patient Treatment Data
Date Received: 06/21/2022 Patient Sequence Number: 1
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