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 16 FRENCH

Device Problem Low Readings (2460)

Patient Problems Death (1802); Fever (1858); Sweating (2444)

Event Date 08/08/2018

Event Type  Death  

Manufacturer Narrative

This medical device report is filed retrospectively following fda observation number 4 received by degania medical devices pvt.Ltd.During the fda inspection of 4-7 of november 2019.The observation was related to the fact that degania medical devices pvt.Ltd.Did not establish procedures for reporting mdrs to fda as a manufacturer.Till then all complaints related to the devices produced by dmd were assessed for mdr reportability and submitted as necessary to fda by degania silicone ltd.Another q medical devices division closely affiliated with dmd.Dmd capa number 73/19 was issued to address the observation; one of the capa actions requires dmd to perform retrospective review of all the complaints received during 2018 and 2019 and submit to fda retrospective mdrs for the reportable events (with reference to original reported to fda.The event was reported to fda by dsl with the report #8030107-2018-003.In summary, there was lack of clarity whether the inaccurate temperture measurement was due to a device malfunction or due to an inherent limitation of urinary temperature measurement when urine output is low.Either way, the medical implication of delayed fever reduction in febrile infected icu-patients is unclear.The current data do not support intensive active fever reduction in these patients to improve mortality.There is no clear link between the inaccurate temperature reading to the patient death 3 days later.Attached the updated clinical commentary from the medical consultant dated (b)(6) 2018.

Event Description

This is retrospective submission, following reassessment of our customer complaints during period 2018-2019.Customer's text: according to the reporter, post -operatively, the device measured wrong temperature while it was used on patient.It was reported that the patient was sweating but the device showed a temperature of 34 degree celsius.It was stated that a spot check measurement at the ear was done and showed 41.4 degree celsius.The customer reported that there was a patient death and cause was asked but unknown.".

• 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: 10709883
• MDR Text Key: 212244903
• Report Number: 3005483737-2020-00023
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: 16 FRENCH
• Device Catalogue Number: 102201101680TY
• Device Lot Number: S18005977
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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