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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 FLEXTEND SKIN BARRIER WITH TAPE BORDER

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HOLLISTER INCORPORATED NEW IMAGE TWO-PIECE POUCHING SYSTEM NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER Back to Search Results
Catalog Number 14603
Device Problems Inadequacy of Device Shape and/or Size (1583); Inadequate User Interface (2958)
Patient Problem Laceration(s) (1946)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
No sample received and no lot number provided. Without the sample or lot number hollister is unable to perform a full investigation regarding the event. Trend analysis conducted and no negative trends observed. End user stated that she did not know that she was cutting her barrier opening too small causing it to cut into her stoma.
 
Event Description
It was reported that an end user's stoma was bleeding and she couldn't figure out why. She went to the er where the bleeding area was cauterized. She later found out that the ostomy barrier edges that she was cutting to fit her stoma, was being cut too small, causing it to rub against and cut her stoma causing it to bleed. She has since cut the barrier opening bigger and it is no longer cutting her stoma.
 
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Brand NameNEW IMAGE TWO-PIECE POUCHING SYSTEM
Type of DeviceNEW IMAGE FLEXTEND 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 Key8888582
MDR Text Key154148010
Report Number1119193-2019-00035
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 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14603
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 Received08/06/2019
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: 08/13/2019 Patient Sequence Number: 1
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