SMART RELIEF TENS THERAPY BACK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-28 for SMART RELIEF TENS THERAPY BACK manufactured by Chattem.

Event Text Entries

[87592654] Initial information regarding this unsolicited case from united states was received from a patient on (b)(6) 2017. This case concerns a female patient of unspecified age who complained that smart relief tens therapy (icy hot smart relief tens therapy) pads were peeling skin on her hip area around the cheek of her butt, it hurt the first day, then the second day it was worse and had red spots where the pads were pulled off. No past drugs, relevant medical history or concurrent conditions and concomitant medications were reported. It was reported that the patients son recommend smart relief tens therapy for her erratic nerve. On (b)(6) 2017, the patient started using smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date 31-jul-2019) for erratic nerve. The electrode pad lot/batch number: b-17-01-08, expiry date: 30-sep-2019 and unit serial number was (b)(4). On the same day ((b)(6) 2017), the pads were peeling the skin on the hip area around the cheek of her butt. It hurt the first day ((b)(6) 2017), then the second day it was worse (latency same day). Reportedly, there were red spots where the pads were pulled off (onset date: (b)(6) 2017; latency same day). The patient was advised to discontinue use (date unknown). Action taken: drug withdrawn nos. Corrective treatment: not reported. Outcome: unknown. Seriousness criteria: important medical event (application site peeling).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1022556-2017-00007
• MDR Report Key: 6899928
• Report Source: CONSUMER
• Date Received: 2017-09-28
• Date of Report: 2017-09-11
• Date of Event: 2017-09-10
• Date Mfgr Received: 2017-12-13
• Date Added to Maude: 2017-09-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: HEATHER SCHIAPPACASSE
• Manufacturer Street: 55 CORPORATE DRIVE 55B-220A
• Manufacturer City: BRIDGEWATER NJ 08807
• Manufacturer Country: US
• Manufacturer Postal: 08807
• Manufacturer Phone: 9089817289
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SMART RELIEF TENS THERAPY BACK
• Generic Name: TRANSCUTANEOUS NERVE STIMULATOR
• Product Code: NUH
• Date Received: 2017-09-28
• Returned To Mfg: 2017-10-02
• Lot Number: 17E111
• Device Expiration Date: 2019-07-31
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHATTEM
• Manufacturer Address: 1715 WEST 38TH STREET CHATTANOOGA TN 37409 US 37409

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-09-28