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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

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HOLLISTER INCORPORATED NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER Back to Search Results
Catalog Number 11204
Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)
Patient Problem Tissue Damage (2104)
Event Date 05/24/2019
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review not possible because not number not known. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed. The root cause of the stoma content leakage cannot be determined.
 
Event Description
It was reported that the end user experienced a burning and itching rash on her skin from her knees to her waist from ileostomy output. She reported that when the hollister barrier got wet from her output, it would not adhere to her skin and leak. She went to the er and was hospitalized overnight. She was discharged home on ciprofloxacin and fluconazole. Hollister is sending her a convex barrier product to try.
 
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Brand NameNEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Type of DeviceNEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
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 Key8687597
MDR Text Key147721985
Report Number1119193-2019-00023
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 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number11204
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 Received06/04/2019
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2019 Patient Sequence Number: 1
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