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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX TAPE BORDERED PRE SIZED BARRIER

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HOLLISTER INCROPORATED NEW IMAGE CONVEX TAPE BORDERED PRE SIZED BARRIER Back to Search Results
Catalog Number 14905
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 05/09/2022
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. Root cause of reported skin irritation under the tape border of barrier cannot be determined.
 
Event Description
It was reported that an end user started developing irritation under the tape border of his hollister ostomy barrier 3 weeks ago. The end user reported that the doctor prescribed triamcinolone and he uses gauze to cover it. He reported that the doctor also prescribed a powder but it furthered the irritation. Hollister is sending the end user samples of skin barriers with the tape border.
 
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Brand NameNEW IMAGE CONVEX TAPE BORDERED PRE SIZED BARRIER
Type of DeviceNEW IMAGE CONVEX TAPE BORDERED PRE SIZED 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 Key14347926
MDR Text Key291314124
Report Number1119193-2022-00014
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 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14905
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2022
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: 05/10/2022 Patient Sequence Number: 1
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