MAUDE Adverse Event Report: DJO LLC STEAM PACK NCP PACKAGED SINGLE; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Model Number 1002

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that allegedly the hotpac burst inside the microwave and caught fire from a pocket.There was no injury or damage to the microwave reported.Hotpac was disposed of in a fire hazard bag.Photos available of the microwave or hotpac.Additional reporting on this event will be provided as a supplemental report to this document if the device is returned or additional information is received.

Event Description

It was reported that allegedly the hotpac burst inside the microwave and caught fire from a pocket.There was no injury or damage to the microwave reported.Hotpac was disposed of in a fire hazard bag.

• Brand Name: STEAM PACK NCP PACKAGED SINGLE
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• 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 ; 5128346301
• MDR Report Key: 18984545
• MDR Text Key: 338677658
• Report Number: 9616086-2024-00011
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E317265
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Weight: 61 KG