MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E7510-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post surgery of heart defect repair, there were burn marks noted on patient's skin from return pad placement which was diagnosed as first degree burn.It was a size of (b)(6).Burn location on the scapula of the patient and treated by using topical creams.
Additional Manufacturer Narrative
Additional information: evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.The provided information was not adequate to determine if the device met specification.The picture showed a rem pad with the backing in place.Without the product a detailed investigation could not be performed.The file will be closed as unconfirmed at this time.If additional information is obtained, or the product is returned, we will re-open this investigation.The instructions for use (ifu) states: select a well vascularized, convex area in close proximity to the surgical site for patient return electrode application.Avoid scar tissue, bony prominences, excessive adipose tissue, and areas where fluid may pool.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7967244
• Report Number: 1717344-2018-01340
• Device Sequence Number: 13508294
• Product Code: GEI
• UDI-Device Identifier: 10884524001043
• UDI-Public: 10884524001043
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 01/23/2020
• Device Model Number: E7510-25
• Device Catalogue Number: E7510-25
• Device Lot Number: 80230208X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Weight: 17