MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. UNK_PATIENT RETURN ELECTRODES - REUSABLE; MEGA SOFT PHONE CABLE 4.4M (14-4")

Catalog Number UNK_PATIENT RETURN ELECTRODES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date unk.Batch # unk.This report is related to a database review; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing eumdr-megadyne disposable electrode/ utilization and descriptive analysis of megadyne disposable electrode.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 20,467 patients had bleeding peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.2,418 patients had surgical site infection peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.4,611 patients had sepsis peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.1,174 patients had wound disruption peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.49 patients had tissue damage peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.

• Brand Name: UNK_PATIENT RETURN ELECTRODES - REUSABLE
• Type of Device: MEGA SOFT PHONE CABLE 4.4M (14-4")
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 9572381
• MDR Text Key: 174477262
• Report Number: 1721194-2020-00006
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PATIENT RETURN ELECTRODES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other