MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC LEADWIRE ADAPTOR V2.0 NO USB; LEADWIRE ADAPTOR V2.0 NO USB/

Model Number 100-1020-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

Patient reported experiencing severe skin irritation while wearing the patch attached to the black lead of the lwa.Patient mentioned burning sensation, scarring and raised lymph nodes.Patient reported that the collar bone to armpits were swollen.Patient also had pain in the shoulder to elbow and from back of the armpit area.Patient stated the black lead was hotter than normal to the touch.Patient reported that the electrode attached to the black lead was melted and the device was not being charged.Patient went to the emergency room (er) and was given antibiotics.The device was not accidently damage during usage.Patient has no implantable devices.Patient states no skin irritation or allergies.

Manufacturer Narrative

It was reported that the patient was experiencing sesver skin irriattion.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is unable to be confirmed as there are no images of patient skin irritation and any skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesive.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.

• Brand Name: LEADWIRE ADAPTOR V2.0 NO USB
• Type of Device: LEADWIRE ADAPTOR V2.0 NO USB/
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 17269706
• MDR Text Key: 318553995
• Report Number: 2133409-2023-00036
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100-1020-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: VERMED ELECTRODE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Female