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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT FLAT BARRIER RING ADAPT FLAT BARRIER RINGS 2"

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HOLLISTER INCORPORATED ADAPT FLAT BARRIER RING ADAPT FLAT BARRIER RINGS 2" Back to Search Results
Catalog Number 7805
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 11/13/2018
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 skin issue. This will continue to be monitored in hollister's post marketed complaint system and actions will be taken if/when indicated.
 
Event Description
It was reported that end user used a piece of product to cover an open cut for 36 hours on her thumb. Days later, a callous formed in the area of the cut with a dark center. The dermatologist thinks the product irritated the skin and caused a reaction. The dermatologist scraped the lesion and sent it to the lab for culture.
 
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Brand NameADAPT FLAT BARRIER RING
Type of DeviceADAPT FLAT BARRIER RINGS 2"
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 Key8137291
MDR Text Key129458971
Report Number1119193-2018-00045
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 Nurse Practitioner
Type of Report Initial
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number7805
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 Received11/29/2018
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: 12/06/2018 Patient Sequence Number: 1
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