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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI AVENTIS U.S. LLC ICY HOT SMART RELIEF BACK REFILL PADS OTHER

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SANOFI AVENTIS U.S. LLC ICY HOT SMART RELIEF BACK REFILL PADS OTHER Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
My shoulder never bothered me, so why it's a problem now makes no sense [unspecified disorder of joint of shoulder region]. Case narrative: initial information received on14-jul-2020 from united states regarding an unsolicited valid serious case received from the patient. This case involves an unknown age female patient who reported that her shoulder never bothered her, so why it's a problem now makes no sense, while she was using medical device smart relief tens therapy (icy hot smart relief back refill pads). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient started using smart relief tens therapy pads (strength, dose, route, frequency, lot/batch number: unknown) for an unknown indication. The patient reported that she had icy hot tens that was effective on my lower back. Since the patient need new pads, she had not used it lately. Patient reported that he did exercise a lot, using a plethora of methods from tai chi to fencing and so he would not be having as many physical problems. She even carried up to 80 lb boxes/crates of construction equipment parts, her shoulder never bothered her so why it was a problem now makes no sense to her (onset date and latency: unknown). Action taken: unknown. Corrective treatment: not reported. Event outcome: unknown seriousness criteria: medically significant.
 
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Brand NameICY HOT SMART RELIEF BACK REFILL PADS
Type of DeviceOTHER
Manufacturer (Section D)
SANOFI AVENTIS U.S. LLC
55 corporate drive
bridgewater 08807
Manufacturer (Section G)
SANOFI AVENTIS U.S. LLC
55 corporate drive
bridgewater 08807
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key10326152
MDR Text Key208191501
Report Number3003496686-2020-00001
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/27/2020 Patient Sequence Number: 1
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