MAUDE Adverse Event Report: CYMEDICA ORTHOPEDICS, INC. CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM; CYMEDICA ORTHOPEDICS® QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM

Model Number	QB-1000-207
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint failure was not able to be recreated - complaint unit was not returned to cymedica for further investigation.Per customer service, replacement electrodes were sent to customer for replacement of old electrodes from complaint unit.Per e-mail communication, patient used same set of electrodes since late august 08/2020 without application of electrode gel.Images of electrodes supplied by customer exhibited worn hydrogel surface.Edges of hydrogel layer found peeling away/missing at electrode edges.Worn/dry electrodes result in poor conduction requiring higher levels of stimulation with potential of discomfort and burning.Dry electrodes are to be replaced with fresh electrodes.Cs communication with customer emphasized need to clean electrodes, utilize covers post-use to retain hydrogel surface moisture/cleanliness, and application of electrode gel to aid electrode conduction and moisture.
Event or Problem Description
On october 29, 2020 patient contacted cymedica customer service regarding burns he received from the electrodes.The "burn" marks are healed now; please take note that he used the same set of pads since late august.The patient did not use gel.Customer service shipped him new electrodes and re-educated him on use/care etc.

• Brand Name: CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM
• Common Device Name: CYMEDICA ORTHOPEDICS® QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM
• Manufacturer (Section D): CYMEDICA ORTHOPEDICS, INC.; 19120 n. pima ave.; suite 135; scottsdale AZ 85255
• MDR Report Key: 10853001
• Report Number: 3011466827-2020-00003
• Device Sequence Number: 16905545
• Product Code: IPF
• UDI-Device Identifier: 00854691008162
• UDI-Public: 00854691008162
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K150413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/29/2022
• Device Model Number: QB-1000-207
• Device Catalogue Number: QB-1000-207
• Device Lot Number: 17002409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Weight: 73