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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEGANIA MEDICAL DEVICES PVT. LTD TEMPERATURE SENSING CATHETER; TEMPERATURE SENSOR CATHETER

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DEGANIA MEDICAL DEVICES PVT. LTD TEMPERATURE SENSING CATHETER; TEMPERATURE SENSOR CATHETER Back to Search Results
Model Number 16 FRENCH
Device Problem Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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.Upon inspection of the unused samples from the complained lots and also one actual used sample which is showed incorrect temperature, we were unable to confirm the problem in catheters.All the measurement were conforming to the specification.
 
Event Description
This is retrospective submission, following reassessment of our customer complaints during period 2018-2019.Customer's text: according to the reporter, the unit had 8-10 foley catheters were used, 16fr, and were all providing wrong temperature measurements: ie in one case the measurement of the patient's temperature was displayed as 40 degrees c for 4 days whereas his temperature has never reached that level as measured by other means of measurements and after the first 24 h he had no fever.In another case, the measurement was displayed for a few seconds and then disappeared from the monitor.We personally witnessed these events in order to verify the claim.We cannot be certain as per above if this is an issue of the sensor or the cable.The hospital is going to investigate the possibility of a problem on the monitor's temperature module but this means that all their monitors are broken and it is not probable".
 
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Brand Name
TEMPERATURE SENSING CATHETER
Type of Device
TEMPERATURE SENSOR 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 Key10798611
MDR Text Key227878797
Report Number3005483737-2020-00030
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K063442
Number of Events Reported1
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 11/06/2020
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 Number16 FRENCH
Device Catalogue Number102201101663BI
Device Lot NumberV18028029
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2019
Initial Date FDA Received11/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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