MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH

Model Number	MCT 1L
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fainting (1847); Skin Irritation (2076)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per patient user guide sup559, patients are instructed to not use the patch if they have known allergies to nickel or other metals, and to inform their physician if they have known sensitivity to medical adhesives.The patient is also informed in the user guide that reddening can occur during the normal use of patch, and that if they develop skin irritation they should remove the patch and seek medical attention.The skin irritation reported by the patient was experiencing, "itchy, pulled skin off, very red, ripped off the entire left side, bleeding, blisters", and to ensure patient comfort, the patient was offered mct 3 lead device that provides electrodes for patients with skin sensitives or allergies.The patient stated that the device is already removed and mailed back (not received back for evaluation).No additional information is known to braemar manufacturing, llc at this time.
Event or Problem Description
On (b)(6) 2019, patient notified lifewatch services, inc.Of skin irritation/blisters, including allegation that patient passed out from pain associated with event.Note: become aware date is 05/28/2019, per complaint case generated (b)(4).
Event or Problem Description
On (b)(6) 2019, patient notified (b)(4), inc.Of skin irritation/blisters, including allegation that patient passed out from pain associated with event.Note: become aware date is (b)(6) 2019, per complaint case generated ((b)(4)).
Additional Manufacturer Narrative
Per patient user guide sup559, patients are instructed to not use the patch if they have known allergies to nickel or other metals, and to inform their physician if they have known sensitivity to medical adhesives.The patient is also informed in the user guide that reddening can occur during the normal use of patch, and that if they develop skin irritation they should remove the patch and seek medical attention.The skin irritation reported by the patient was experiencing, "itchy, pulled skin off, very red, ripped off the entire left side, bleeding, blisters", and to ensure patient comfort, the patient was offered mct 3 lead device that provides electrodes for patients with skin sensitives or allergies.No additional information is available at present regarding the case.Attempts to further contact the patient were unsuccessful.No additional qualitative data (e.G., pictures) is available for case review, to address the claims identified.Per clinical affairs review by qualified person ((b)(6) , rn, msn, cde), pain is a subjective symptom and may vary from person to person.The case was reported to us fda as 2019_00007 due to the patient's claim of passing out from pain.A root cause analysis position paper for skin irritation is available and has been identified in the case file (03-06816 rev.A).The patient self-treated with alcohol, which may exacerbate skin irritation by further drying and irritating the skin.No conservative care actions were noted in the complaint case.The patient was switched to an alternate device and was able to continue monitoring with alternate electrodes for persons with skin sensitivities or allergies.Although the patient did not finish the monitoring period, it is reasonably concluded by clinical affairs (qualified person, ms.(b)(6) ) that the patient's condition did not worsen.The patient did not seek or necessitate medical treatment to address the skin irritation and was able to switch to the alternate system.No capa actions will be taken to address the event, as no device deficiency could be confirmed or replicated.Patient use case factors were identified.Case will be tracked and trended.Per 03-06816 rev.A, the case is categorized as "mild to moderate injury affecting the epidermis and dermis, responsive to conservative care within 7 days".No additional information is known to (b)(4), inc.And braemar manufacturing, llc at this time.

• Brand Name: LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH
• Common Device Name: LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan, mn MN 55121
• MDR Report Key: 8739030
• Report Number: 2133409-2019-00007
• Device Sequence Number: 1591090
• Product Code: DSI
• UDI-Device Identifier: 00850725007040
• UDI-Public: 00850725007040
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: MCT 1L
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR