MAUDE Adverse Event Report: BIO-DETEK INC. PRO-PADZ; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Catalog Number 8900-4006

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Tears (2516)

Event Date 10/25/2019

Event Type  malfunction  

Event Description

Zoll defib pads causing skin integrity issues when removed 24hours post-op.Patients are receiving skin tears when removed even when adhesive remover is being used.

• Brand Name: PRO-PADZ
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): BIO-DETEK INC.; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 9568812
• MDR Text Key: 174301624
• Report Number: 9568812
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8900-4006
• Device Lot Number: 0919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other