MAUDE Adverse Event Report: MMJ SA DE CV (USD) WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number 5016000

Device Problems Device Emits Odor (1425); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device had burning smell.It was stated there was no allegation of patient death or serious injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: WARMTOUCH
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MMJ SA DE CV (USD); ave. henequen no 1181 desarrol; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave. henequen no 1181 desarrol; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder,co, MA 80301 ; 3035306582
• MDR Report Key: 7426725
• MDR Text Key: 105405470
• Report Number: 2936999-2018-00261
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10884521141100
• UDI-Public: 10884521141100
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K123083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5016000
• Device Catalogue Number: 5016000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2018
• Date Device Manufactured: 12/01/2015
• 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