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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TWO-PIECE POUCHING SYSTEM NEW IMAGE FLEXWEAR SKIN BARRIER WITH TAPE BORDER

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HOLLISTER INCORPORATED NEW IMAGE TWO-PIECE POUCHING SYSTEM NEW IMAGE FLEXWEAR SKIN BARRIER WITH TAPE BORDER Back to Search Results
Catalog Number 14203
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Breakdown (2681)
Event Date 11/18/2019
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 lot number not known. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed. The root cause of the reported blisters under the skin barrier cannot be determined.
 
Event Description
It was reported that the end user experienced open blisters, extending beyond the edges of the barrier after using 7917 skin gel protective wipes along with this 14203 barrier. The end user was treated with oral prednisone, nystatin powder and neosporin. End user will be sent samples of another barrier product to try.
 
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Brand NameNEW IMAGE TWO-PIECE POUCHING SYSTEM
Type of DeviceNEW IMAGE FLEXWEAR 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 Key9401991
MDR Text Key168829439
Report Number1119193-2019-00043
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 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14203
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 Received11/25/2019
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: 12/03/2019 Patient Sequence Number: 1
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