MAUDE Adverse Event Report: DJO LLC VECTRA GENISYS; STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Model Number 2761

Device Problem Unintended Electrical Shock (4018)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the unit allegedly shocked and caused a burn to patient during treatment.Enovis has received sufficient information regarding the reported burn the degree of burn is unknown and medical intervention was required.Patient was treated with antibiotic cream and a band aid.After performing functional and electrical testing, the technician was unable to duplicate the reported complaint.The product met manufacturer specifications.

Event Description

It was reported that the unit allegedly shocked and caused a burn to patient during treatment.

• Brand Name: VECTRA GENISYS
• Type of Device: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
• 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: 16026891
• MDR Text Key: 305936456
• Report Number: 9616086-2022-00032
• Device Sequence Number: 1
• Product Code: GZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 27335 SERIAL (B)(4).
• Patient Outcome(s): Other