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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX PRESIZED OSTOMY BARRIER

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HOLLISTER INCROPORATED NEW IMAGE CONVEX PRESIZED OSTOMY BARRIER Back to Search Results
Catalog Number 14905
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Itching Sensation (1943)
Event Date 12/01/2021
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Since lot number not provided dhr review not possible. Sample not returned so sample evaluation not possible. Patient's weight and race not known. Root cause of reported itchy and bleeding skin under the barrier cannot be determined.
 
Event Description
It was reported that an end user was using the hollister new image ostomy barrier and her skin started itching under the barrier; she would scratch it and it would start bleeding. The doctor prescribed nystatin. That did not help. She will be trialing a different formulation of hollister's ostomy barriers to see if that makes a difference.
 
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Since lot number not provided dhr review not possible. Sample not returned so sample evaluation not possible. Patient's weight and race not known. Root cause of reported itchy and bleeding skin under the barrier cannot be determined.
 
Event Description
It was reported that an end user was using the hollister new image ostomy barrier and her skin started itching under the barrier; she would scratch it and it would start bleeding. The doctor prescribed nystatin. That did not help. She will be trialing a different formulation of hollister's ostomy barriers to see if that makes a difference.
 
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Brand NameNEW IMAGE CONVEX PRESIZED OSTOMY BARRIER
Type of DeviceNEW IMAGE CONVEX PRESIZED 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 Key13002976
MDR Text Key285327978
Report Number1119193-2021-00038
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 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
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 Received12/01/2021
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 Unkown

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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