MAUDE Adverse Event Report: DEGANIA SILICONE LTD MON-A-THERM¿ FOLEY CATHETERS WITH TEMPERATURE SENSORS; 2W SIL.FOLEY CATH 16FR W/TEMP.SENSOR

Model Number 16FR

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the actual sample did not confirm deviation.The complaint considered to be not justified.

Event Description

According to the reporter, the unit had a wrong measurement.The customer indicated that there was no patient involvement.

• Brand Name: MON-A-THERM¿ FOLEY CATHETERS WITH TEMPERATURE SENSORS
• Type of Device: 2W SIL.FOLEY CATH 16FR W/TEMP.SENSOR
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer Contact: katia kayam ; degania bet; degania bet, jordan valley 15130-00 ; IS 1513000
• MDR Report Key: 9896799
• MDR Text Key: 202728839
• Report Number: 8030107-2019-00025
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16FR
• Device Catalogue Number: 102201101663BI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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