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

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.

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: based on additional information received on 24-jul-2020; this case qualifies for nullification (the tens was never the problem, but it was disappointing to hear it has been discontinued) initial information received on 14-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).Upon follow up, patient reported that he has returned the icy hot patches.She said that tens was never the problem.Action taken: unknown.Corrective treatment: not reported.Event outcome: unknown.Seriousness criteria: medically significant.Additional information received on 24-jul-2020 from the patient: this case qualifies for nullification (the tens was never the problem, but it was disappointing to hear it has been discontinued).No adverse event.Local comments: downgrade.

• Brand Name: ICY HOT SMART RELIEF BACK REFILL PADS
• Type of Device: OTHER
• Manufacturer (Section D): SANOFI AVENTIS U.S. LLC; 55 corporate drive; bridgewater 08807
• MDR Report Key: 10326152
• MDR Text Key: 208191501
• Report Number: 3003496686-2020-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention