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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHATTEM SMART RELIEF TENS THERAPY BACK TRANSCUTANEOUS NERVE STIMULATOR

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CHATTEM SMART RELIEF TENS THERAPY BACK TRANSCUTANEOUS NERVE STIMULATOR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Bruise/Contusion (1754)
Event Date 03/20/2016
Event Type  Injury  
Event Description
Initial information regarding unsolicited device case was received from a patient on 23-mar-2016. This case involves a (b)(6) years old female patient who was getting blisters, unknown duration after starting smart relief tens therapy (smart relief tens therapy back). Concomitant medication and relevant medical history was not provided. On an unknown date (from over a year), the patient started smart relief tens therapy (lot/batch number, expiration date and other dosing details were unknown). Reportedly, from the past couple of months, patient was getting blisters whenever she took the pad off, and this had never happened before. Patient mentioned that the device gave her very itchy blisters. Action taken: unknown. Information on corrective treatment was not provided. Outcome was unknown. Seriousness criteria: ime. Pharmacovigilance comment: sanofi company comment dated 23-mar-2016: this case concerns a (b)(6) years old female patient who is experiencing blisters. This case cannot be assessed due to lack of information. Moreover, information regarding relevant medical history, concurrent conditions, condition of the skin at the contact area prior to applying the device, history of allergies, concomitant medications and event details will preclude further assessment of this case.
 
Event Description
Initial information regarding unsolicited device case was received from a patient on (b)(6) 2016. This case involves a (b)(6) female patient who was getting blisters, unknown duration after starting smart relief tens therapy (smart relief tens therapy back). Concomitant medication and relevant medical history was not provided. On an unknown date (from over a year), the patient started smart relief tens therapy (lot/batch number, expiration date and other dosing details were unknown). Reportedly, from the past couple of months, patient was getting blisters whenever she took the pad off, and this had never happened before. Patient mentioned that the device gave her very itchy blisters. Action taken: unknown. Information on corrective treatment was not provided. Outcome was unknown. Seriousness criteria: ime. Qa review: the device history files were reviewed at the time of the complaint for any anomaly, deviation or investigation, documented or otherwise that might result in any type of complaint against the lot. No evidence of root cause was found in the device history files. All retains have been examined for correct packaging, seal, missing components, working control unit, legibility of lot numbers /expiration date, correct label and foreign matter. No anomalies were found that could contribute to this complaint. Additional information was received on 28-mar-2016: qa review was added. Pharmacovigilance comment: sanofi company comment dated 23-03-2016: this case concerns a (b)(6)-female patient who developed blisters while on therapy with smart relief tens therapy. This case cannot be assessed due to lack of information. Moreover, information regarding relevant medical history, concurrent conditions, condition of the skin at the contact area prior to applying the device, history of allergies, concomitant medications and event details will preclude further assessment of this case.
 
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Brand NameSMART RELIEF TENS THERAPY BACK
Type of DeviceTRANSCUTANEOUS NERVE STIMULATOR
Manufacturer (Section D)
CHATTEM
1715 west 38th street
chattanooga TN 37409
Manufacturer Contact
kristen sharma
55 corporate drive
55c-235a
bridgewater, NJ 08807
9089812784
MDR Report Key5540589
MDR Text Key41611896
Report Number1022556-2016-00004
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/01/2016 Patient Sequence Number: 1
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