MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	MDS611505A
Health Effect - Clinical Codes	Abrasion (1689); Burn(s) (1757)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Electrodes caused skin abrasion "burn".

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 6993305
• Report Number: 6993305
• Device Sequence Number: 1183783
• Product Code: DRX
• UDI-Device Identifier: 10080196320745
• UDI-Public: (01)10080196320745
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017
• Report Date (Section F): 10/12/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/23/2020
• Device Model Number: MDS611505A
• Device Catalogue Number: MDS611505A
• Device Lot Number: (10)170523S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO OTHER THERAPIES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 83
• Date Report Sent to FDA: 10/12/2017