MAUDE Adverse Event Report: BOVIE MEDICAL MCKESSON; PRIVATE LABEL MCKESSON DISPOSABLE RETURN SPLIT PADS

Catalog Number	22-ESRE
Health Effect - Clinical Code	Skin Tears (2516)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility alleged the device tore the patient's skin.Device has not yet been made available from the user for evaluation.Limited information has been made available at this time as the reporter has not responded to our multiple requests for information.We will continue to follow up with the user for additional information.A follow up report will be submitted once additional information is received.
Event or Problem Description
The user facility is alleging that our mckesson branded 22-esre disposable grounding pads, lot # 2018-03-23 is "tearing their older patient's skin.".
Additional Manufacturer Narrative
The user facility was contacted five times via email and did not respond to our requests for additional information or to return the device for evaluation.Based on this information, this can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: MCKESSON
• Common Device Name: PRIVATE LABEL MCKESSON DISPOSABLE RETURN SPLIT PADS
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton rd; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL; 5115 ulmerton rd.; clearwater FL 33760
• Manufacturer Contact: andy ferrell ; 3034 owen dr.; antioch, TN 37013 ; 6159645553
• MDR Report Key: 13653377
• Report Number: 3007208013-2021-00015
• Device Sequence Number: 20390664
• Product Code: GEI
• UDI-Device Identifier: 20612479217458
• UDI-Public: 20612479217458
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K092761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: Health Professional
• Device Expiration Date: 03/23/2021
• Device Catalogue Number: 22-ESRE
• Device Lot Number: 2018-03-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown