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

Model Number E7507

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, on the 3 devices, there was tearing, bruising and redness of skin under the bovie pad.Tissue damage or unexpected tissue loss occurred.

• Brand Name: VALLEYLAB
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13253433
• MDR Text Key: 283781376
• Report Number: 1717344-2022-00050
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524000077
• UDI-Public: 10884524000077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: E7507
• Device Catalogue Number: E7507
• Device Lot Number: 21333321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other