MAUDE Adverse Event Report: DJO LLC INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2738

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient allegedly had to undergo a surgery on her shoulder after treatment of electric stimulation at the physical therapy clinic.The djo investigation is ongoing and a supplemental will be filed upon completion.

Event Description

It was reported that the patient allegedly had to undergo a surgery on her shoulder after treatment of electric stimulation at the physical therapy clinic.

• Brand Name: INTELECT TRANSPORT COMBO PKG US STD
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el flirdo; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 11457270
• MDR Text Key: 239107280
• Report Number: 9616086-2021-00004
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2738
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other