MAUDE Adverse Event Report: DJO LLC LEGEND XT 4CH STIM PKG US STD; STIMULATOR, MUSCLE, POWERED

Model Number	2786
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the the unit allegedly caused a 1st degree burn to patient during stim treatment.After performing functional and electrical testing, the technician was unable to duplicate the reported complaint.The product met manufacturer specifications.Possible root causes include moisture or misapplication of the electrodes.
Event or Problem Description
It was reported that the the unit allegedly caused a burn to patient during stim treatment.

• Brand Name: LEGEND XT 4CH STIM PKG US STD
• Common Device Name: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 14837167
• Report Number: 9616086-2022-00016
• Device Sequence Number: 5245812
• Product Code: IPF
• UDI-Device Identifier: 00888912294140
• UDI-Public: 00888912294140
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2786
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown