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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED KARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING

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HOLLISTER INCORPORATED KARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING Back to Search Results
Model Number 3228
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Lot number not provided so dhr review is not possible. Sample not returned so a sample evaluation is not possible. Trend data reviewed and no adverse trend observed. The root cause of the skin irritation under the tape and barrier cannot be determined.
 
Event Description
It was reported that an end user developed sores around the stoma under the hollister ostomy barrier in (b)(6) 2019 and was prescribed oral antibiotics which cleared it up. Since (b)(6), he has been having problems with sores and ulcers under the tape and barrier portion of the barrier on and off. He is under the care of a wocn who has used gauze pads with silver to apply to the deep ulcers and has now prescribed steroid powder for the contact dermatitis.
 
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Brand NameKARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING
Type of DeviceKARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville, il
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft, va
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville, il 
3602170
MDR Report Key10302010
MDR Text Key199680713
Report Number1119193-2020-00016
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3228
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 Received07/07/2020
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: 07/21/2020 Patient Sequence Number: 1
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