MAUDE Adverse Event Report: UNKNOWN UNKNOWN; DEFIBRILLATOR PADS

Catalog Number UNKNOWN

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

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 07/17/2018

Event Type  malfunction  

Event Description

After surgical procedure for left hip hemiarthroplasty, defibrillator pads were removed from the anterior chest and it was noted patient had a skin tear with mild bleeding/bruising due to the very fragile skin.Skin was dress with xeroform, plain dressings and a tegaderm occlusive dressing.

• Brand Name: UNKNOWN
• Type of Device: DEFIBRILLATOR PADS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7776566
• MDR Text Key: 116887399
• Report Number: 7776566
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA