MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT LUBRICATING DEODORANT

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.

• Brand Name: ADAPT LUBRICATING DEODORANT
• Type of Device: ADAPT 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 Key: 5428012
• MDR Text Key: 38038702
• Report Number: 1119193-2016-00001
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 78501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Date Report to Manufacturer: 01/11/2016
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/10/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 86