MAUDE Adverse Event Report: DJO LLC VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL; STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Model Number	2761
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient allegedly experienced a second degree burn from treatment.Djo continues to investigate and if further information is received, djo will provide a supplemental once the investigation is complete.
Event or Problem Description
It was reported that the patient allegedly experienced a second degree burn from treatment.
Additional Manufacturer Narrative
It was reported that the patient allegedly experienced a second degree burn from treatment.The device was returned to djo and the technician performed a thorough investigation.The product passed all functional testing and met specifications.

• Brand Name: VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
• Common Device Name: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 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; carlsbad; vista, CA 92010 ; 5128346301
• MDR Report Key: 12628361
• Report Number: 9616086-2021-00016
• Device Sequence Number: 11848203
• Product Code: GZI
• UDI-Device Identifier: 00888912292849
• UDI-Public: 00888912292849
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/08/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown