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 12 FRENCH

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

We were unable to confirm this event since the actual sample is unavailable and the device history record and retain samples testing did not reveal any non conformity.So, the complaint was considered as not justified.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 (b)(4) 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 mdr report #8030107-2020-00021 filed by degania silicone ltd.).

Event Description

This is retrospective submission, following reassessment of our customer complaints during period 2018-2019.Customer's text: according to the reporter, during use of device, the device's temperature monitoring did not work.It was reported that they have swapped catheters in four cases.There was no reported patient outcome.

• 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: 10497910
• MDR Text Key: 206819270
• Report Number: 3005483737-2020-00017
• 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: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: 12 FRENCH
• Device Catalogue Number: 102201101280TY
• Device Lot Number: S17004479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 09/05/2020
• 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