MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT,EPATCH,CM,BTH

Device Problems Overheating of Device (1437); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Product has been requested for return.Further information will be provided when investigation is complete.

Event Description

Customer reported that while patch was being charged, it "popped and smoked" there was no report of death or serious injury.

Manufacturer Narrative

Engineering evaluation was completed on 18-may-2023, results are as follows: device was inspected for general physical integrity.The branding was worn and minor cosmetic defects in the casing were observed.No problems found.Device started charge with fast charger at 9:12 am at 123.9 ma.Device was charged fully at 10:02 am at 104.7 ma.Total device charge time: 50 minutes.Device charged fully; maximum temperature observed was 93.4f.No sparks, smoke, or popping sounds were identified during this test.No problems found.The external casing was removed, and inspection of internal components was performed.No melted or burnt components were identified.No problems found.Conclusion: engineering evaluation found minor cosmetic defects but was unable to replicate the reported complaint.The reported event was unconfirmed.No problems found.

• Brand Name: UNIT,EPATCH,CM,BTH
• Type of Device: UNIT,EPATCH,CM,BTH
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan
• MDR Report Key: 16950828
• MDR Text Key: 315456393
• Report Number: 2133409-2023-00022
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 05/18/2023
• 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: Initial
• Patient Sequence Number: 1