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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FORMAFLEX TAPE BORDERED STRETCH TO FIT BARRIER

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HOLLISTER INCROPORATED NEW IMAGE FORMAFLEX TAPE BORDERED STRETCH TO FIT BARRIER Back to Search Results
Catalog Number 14104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 06/01/2022
Event Type  Injury  
Event Description
It was reported that an ostomate using hollister new image barrier developed skin irritation around the stoma a month ago. End user reported that there was effluent leakage around the stoma and the skin became irritated and weepy. She reported using 1% silver sulfadiazine ointment for this irritation around the stoma but it is no longer helping. Hollister is sampling some alternative barriers for her to try.
 
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 skin irritation next to the stoma under the ostomy barrier cannot be determined.
 
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Brand NameNEW IMAGE FORMAFLEX TAPE BORDERED STRETCH TO FIT BARRIER
Type of DeviceNEW IMAGE FORMAFLEX TAPE BORDERED STRETCH 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 Key14988688
MDR Text Key295714980
Report Number1119193-2022-00023
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 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14104
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2022
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: 07/12/2022 Patient Sequence Number: 1
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