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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH, 5.5CM FER

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APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH, 5.5CM FER Back to Search Results
Model Number 14
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2014
Event Type  malfunction  
Manufacturer Narrative
The event unit was not returned for evaluation. In the absence of the subject device, it is difficult to determine the root cause. A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections. The exact root cause remains unknown as the device was not returned for evaluation. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016. This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter. Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes. The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies). This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review. In accordance to 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
 
Event Description
(b)(4) - "surgeon used a hooked needle instrument through the port which pulled off the white plastic cap. Plastic fell off inside the patient. Plastic removed from the patient in tact. " patient status - "normal. ".
 
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Brand NameCNO11, GELPOINT PATH, 5.5CM
Type of DeviceFER
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
22872 avenida empresa
rancho santa margarita, CA 92688
9497138233
MDR Report Key6385919
MDR Text Key69328445
Report Number2027111-2017-01489
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/27/2017
Device Model Number14
Device Catalogue Number14
Device Lot Number1213892
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
Treatment
A HOOKED NEEDLE INSTRUMENT
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