MAUDE Adverse Event Report: DEGANIA MEDICAL DEVICES PVT. LTD MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER; TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER

Model Number 14 FRENCH

Device Problem Low Readings (2460)

Patient Problems Pulmonary Dysfunction (2019); Viral Infection (2248)

Event Type  malfunction  

Manufacturer Narrative

There was no temperature failure of the sensor observed during the testing of the possible lot nos.Given below: s18012434, s20006600, s20006439, s20006094, s19004376.The comments received from the customer related to device as given below: relationship to device: not associated with complaint.Customer confirmed via follow up communication that the device was in no way associated with or considered attributable to patient death.Because the patient was sick with covid, the patient died as a result of lung failure in consequence of covid and was listed for transplantation of a new lung.

Event Description

According to the reporter, the device gave readings of 36 degree celsius during operation, however based on the observation of the patient by an experienced professional and patient having increased heart rate, patient's temperature was measured again in the ear and gave 38 degree celsius.Which showed a deviation of 2 degree celsius downwards compared to the device.The patient was sick with covid , and ecmo was running and about 14 days ago the patient died as a result of lung failure in consequence of covid and was listed for transplantation of a new lung.The lot no.Was unknown and no complaint sample available.

• Brand Name: MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER
• Manufacturer (Section D): DEGANIA MEDICAL DEVICES PVT. LTD; plot no. 251, sector-6,; imt manesar; gurgaon, india 12205 0; IN 122050
• Manufacturer (Section G): DEGANIA MEDICAL DEVICES PVT. LTD.; plot no. 251, sector-6; imt manesar; gurgaon, haryana 12205 0; IN 122050
• Manufacturer Contact: ratnamma nair ; plot no. 251, sector-6; imt manesar; gurgaon, haryana 12205-0 ; IN 122050
• MDR Report Key: 11264357
• MDR Text Key: 263841467
• Report Number: 3005483737-2021-00001
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14 FRENCH
• Device Catalogue Number: 102201101480TY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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