INTELECT XT 2CH COMBO PKG 2760

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-05-14 for INTELECT XT 2CH COMBO PKG 2760 manufactured by Djo, Llc.

Event Text Entries

[2636756] Received notification alleging "pt shocked during treatment, possible injury". No serious injury reported as a result of events. Notification of event was received from law office representing the clinic where device was utilized.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9616086-2012-00028
• MDR Report Key: 2577556
• Report Source: 99
• Date Received: 2012-05-14
• Date of Report: 2012-05-14
• Date of Event: 2012-04-18
• Date Mfgr Received: 2012-04-20
• Date Added to Maude: 2012-05-18
• 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
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 1430 DECISION ST
• Manufacturer City: VISTA CA 92081
• Manufacturer Country: US
• Manufacturer Postal: 92081
• Manufacturer G1: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
• Manufacturer Street: CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
• Manufacturer City: TIJUANA 22244
• Manufacturer Country: MX
• Manufacturer Postal Code: 22244
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTELECT XT 2CH COMBO PKG
• Generic Name: ELECTROTHERAPY - CLINIC
• Product Code: IMG
• Date Received: 2012-05-14
• Model Number: 2760
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DJO, LLC
• Manufacturer Address: 1430 DECISION ST, VISTA CA 92081 US 92081

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-05-14