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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 14804
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 07/01/2021
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 may of this year. It was described as burning, red and inflamed. This led to a skin abscess. The end user started going to a wound care clinic in july because it wasn't resolving. During her course of care she has been prescribed cephalexin, doxycycline, and diflucan. She also used lidocaine cream and a foam dressing. The healthcare practitioner did not have a diagnosis for what this is. She is being sent samples of hollister barriers without a tape border. The abscess is now healing nicely and has minimal depth.
 
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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 Key12616115
MDR Text Key275921667
Report Number1119193-2021-00031
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 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14804
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 Received10/06/2021
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: 10/12/2021 Patient Sequence Number: 1
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