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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH

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HOLLISTER INCORPORATED PREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH Back to Search Results
Catalog Number 8901
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
The device history records were reviewed and no issues identified. Root cause of the reported skin infection cannot be determined. (b)(4).
 
Event Description
It was reported that an end user experienced skin irritation, redness and itching under the tape portion of the hollister ostomy barrier. He went to the er on (b)(6) 2020 for this and was diagnosed with impetigo and prescribed mupirocin ointment to apply to the affected area. The area cleared up but it started up again when he used the tape over that area again. He reports having sensitive skin. Irritation has occurred before when using another ostomy appliance brand. Hollister will send him product to sample that does not have a tape border.
 
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Brand NamePREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH
Type of DevicePREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH
Manufacturer (Section D)
HOLLISTER INCORPORATED
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. 60048-3781
8476802170
MDR Report Key10535544
MDR Text Key207127197
Report Number1119193-2020-00024
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number8901
Device Lot Number0F152
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/15/2020 Patient Sequence Number: 1
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