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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM

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HOLLISTER INCROPORATED PREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM Back to Search Results
Catalog Number 85711
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Event Date 12/31/2021
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed for tape causing skin irritation. Since lot number not provided dhr review not possible. Sample not returned so sample evaluation not possible. Patient's weight and race not known. Root cause of reported skin irritation under the tape border cannot be determined.
 
Event Description
It was reported that about 3 weeks ago an end user started noticing skin irritation, itchy and painful skin under the tape border of the hollister ostomy appliance. She attempted to treat it at home with bacitracin ointment but it did not help. She called her doctor who prescribed cefoxitin oral antibiotics as a preventive against a bacterial skin infection. The doctor did not see her or the irritated area on her skin before prescribing. End user called hollister at which time the crusting technique was explained to her. She is now using the stoma powder under the tape border for the irritated area and the area is clearing up.
 
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Brand NamePREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM
Type of DevicePREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM
Manufacturer (Section D)
HOLLISTER INCROPORATED
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, IL 60048-3781
8476802170
MDR Report Key13284988
MDR Text Key289066469
Report Number1119193-2022-00001
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 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number85711
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/11/2022
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 Unkown

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
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