MAUDE Adverse Event Report: CHATTEM SMART RELIEF TENS THERAPY KNEE AND SHOULDER; TRANSCUTANEOUS NERVE STIMULATOR

Lot Number 14061001

Device Problem Torn Material (3024)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

Initial information regarding this unsolicited device case from united states was received from a patient on 11-may-2016.This case concerns a female patient of unspecified age who had blood clots in her right leg, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder) as a device.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.On an unknown date, the patient commenced therapy with smart relief tens therapy at an unspecified frequency (lot/batch number: 14061001 and expiry date: 30-dec-2016; indication not reported).After an unspecified time, in (b)(6) (year not reported), she developed blood clots in her right leg and had to stop using the device.Reportedly, he was using pads from the refill kit.The patient was released by her doctor recently because the blood clots were gone.Further, it was also reported that she had a hell of a time pulling it off her skin as it was really sticky, difficult to remove from the skin and also tore when attempting to remove.Reportedly, it tore off her skin and this happened last week.She thought she was taking her skin off her bones.She was pulling the tab that was when it tore.Also, she had thrown the torn pad away but still had the other pad.Action taken: stopped temporarily.Corrective treatment: not reported.Outcome: recovered on unknown date.Qa review was performed and investigation findings were reported as "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." seriousness criteria: important medical event.Additional information was received in 12-may-2016 from the quality department: qa review added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 12-05-2016: the follow up information received does not change the previous assessment of this case.Sanofi company comment dated 16-05-2016: this case involves a female patient who experienced clot blood while on treatment with.The causal role of the suspect drug cannot be formally excluded.However, lack of detailed information regarding event details, therapy details, latency, relevant underlying conditions, past drugs etc preclude a comprehensive assessment in this case.

Event Description

Initial information regarding this unsolicited device case from united states was received from a patient on 11-may-2016.This case concerns a female patient of unspecified age who had blood clots in her right leg, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder) as a device.No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported.On an unknown date, the patient commenced therapy with smart relief tens therapy at an unspecified frequency (lot/batch number: 14061001 and expiry date: 30-dec-2016; indication not reported).After an unspecified time, in (b)(6) (year not reported), she developed blood clots in her right leg and had to stop using the device.Reportedly, he was using pads from the refill kit.The patient was released by her doctor recently because the blood clots were gone.Further, it was also reported that she had a hell of a time pulling it off her skin as it was really sticky, difficult to remove from the skin and also tore when attempting to remove.Reportedly, it tore off her skin and this happened last week.She thought she was taking her skin off her bones.She was pulling the tab that was when it tore.Also, she had thrown the torn pad away but still had the other pad.Action taken: stopped temporarily.Corrective treatment: not reported.Outcome: recovered on unknown date.Qa review was performed and investigation findings were reported as "received one electrode from lot no.14061001 for investigation.However, the returned pad was unopened and unused.The consumer did not return the torn pad described in the complaint.Therefore, no investigation is possible at this time.Final conclusion: no investigation possible.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." seriousness criteria: important medical event additional information was received in 12-may-2016 from the quality department: qa review added.Text amended accordingly.Additional information was received in 01-jun-2016 from the quality department: qa review for "unopened and unused" received sample added (no investigation possible).Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 01-06-2016: the follow up information received does not change the previous assessment of this case sanofi company comment dated 16-05-2016: this case involves a female patient who experienced clot blood while on treatment with.The causal role of the suspect drug cannot be formally excluded.However, lack of detailed information regarding event details, therapy details, latency, relevant underlying conditions, past drugs etc preclude a comprehensive assessment in this case.

• Brand Name: SMART RELIEF TENS THERAPY KNEE AND SHOULDER
• Type of Device: TRANSCUTANEOUS 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 Key: 5669214
• MDR Text Key: 45569686
• Report Number: 1022556-2016-00005
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/30/2016
• Device Lot Number: 14061001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other