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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER

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HOLLISTER INCROPORATED NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER Back to Search Results
Catalog Number 13903
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 08/01/2021
Event Type  Injury  
Manufacturer Narrative
Lot number not provided so dhr review not possible. Sample not returned so sample evaluation not possible. Weight not provided so estimate used. The root cause of the skin irritation under the tape border of the barrier cannot be determined.
 
Event Description
It was reported that an end user started experiencing skin irritation under the tape border of the hollister ostomy barrier in april of this year. It was described as red and irritated. This irritation was not going away so he saw his dermatologist in august. The dermatologist gave him steroid injections under the skin and prescribed a steroid topical ointment. It was working well for him and the irritation was going away. When he stopped using the steroid ointment however, the irritation returned. When he called hollister it was suggested that he try a barrier without a tape border. Samples without a tape border have been sent to him to try.
 
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Brand NameNEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
Type of DeviceNEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
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 Key12657795
MDR Text Key277175202
Report Number1119193-2021-00032
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number13903
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 Received10/14/2021
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: 10/19/2021 Patient Sequence Number: 1
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