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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE MENTHOLATUM CO. WELLPATCH WARMING PAIN RELIEF PATCH; PACK, HOT OR COLD, DISPOSABLE
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THE MENTHOLATUM CO. WELLPATCH WARMING PAIN RELIEF PATCH; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Lot Number 1402B9
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Erythema (1840)
Event Date 08/16/2014
Event Type  Injury  
Event Description
Consumer wore heating patch on her back while driving from (b)(6) which caused her to develop a second degree burn.She was treated by her primary care physician and was prescribed silvadene cream.She has been back to see her dr.Twice for follow up visits.Condition is healing well.
 
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Brand Name
WELLPATCH WARMING PAIN RELIEF PATCH
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
THE MENTHOLATUM CO.
707 sterling dr.
orchard park NY 14127
Manufacturer Contact
carol wasteneys
707 sterling dr.
orchard park, NY 14127
7166772500
MDR Report Key4151985
MDR Text Key4767936
Report Number1320681-2014-00006
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/05/2014
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 Lay User/Patient
Device Expiration Date02/28/2016
Device Lot Number1402B9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date08/25/2014
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/05/2014
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
Patient Sequence Number1
Treatment
ATORVASTATIN; ATENOLOL
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight68
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