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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT LUBRICATING DEODORANT

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HOLLISTER INCORPORATED ADAPT LUBRICATING DEODORANT Back to Search Results
Model Number 78501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Respiratory Distress (2045); Reaction (2414); No Code Available (3191)
Event Date 01/06/2016
Event Type  Injury  
Event Description
It was reported that the individual had changed his wife's stoma appliance and added a packet of the adapt lubricating deodorant into the pouch. Shortly thereafter his eyes started watering, he couldn't breath through his nose and he got a headache. The symptoms would come back whenever he was in a room where his wife was or had been. After several days he says he can still taste the chemical product on his lips and can smell it. He went to the doctor who indicated he was reacting to some chemical in the product and prescribed methylpredis alone for 6 days. Doctor advised him to not use the product again.
 
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Brand NameADAPT LUBRICATING DEODORANT
Type of DeviceADAPT LUBRICATING DEODORANT
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister dr
libertyville IL 60048
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
anne riba
2000 hollister dr
libertyville, IL 60048
8476805625
MDR Report Key5428012
MDR Text Key38038702
Report Number1119193-2016-00001
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 01/11/2016,02/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number78501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Home
Date Report to Manufacturer01/11/2016
Date Manufacturer Received01/11/2016
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: 02/10/2016 Patient Sequence Number: 1
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