MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FOOT PEDAL

Model Number FSENCOR01

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to bd for evaluation.The investigation is identified as inconclusive as the device was not returned.Based on the information provided, the definitive root cause is unknown.The device is labeled for reuse.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fsencor01 encor allegedly experienced unintended movement.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient age, gender, and weight was no provided.

• Brand Name: ENCOR FOOT PEDAL
• Type of Device: ENCOR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9203204
• MDR Text Key: 162688269
• Report Number: 2020394-2019-04060
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FSENCOR01
• Device Catalogue Number: FSENCOR01
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1