OC-AUTO FIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for OC-AUTO FIT manufactured by Polymedco.

Event Text Entries

[96210343] On (b)(6) 2017 i assisted my mother-in-law this morning with a stool sample collection kit supplied by her pcp, (b)(6). The oc-auto fit collection kit is the most complicated system i have ever seen, but to give this to a patient that is (b)(6) is just not reasonable. I personally believe this is a waste of money much less the product does not allow the stool testing collection to be proper testing results for the laboratory. The collecting container is too narrow to place a stool sample in. To explain, it is like a mini-mascara container, but yet the entrance to the container is very narrow. I would appreciate this stool sample kit be sent to you for testing by somoene and you will understand a stool sample is not capable of being pushed into the container by the applicator. I am thankful i was here to assist with my mother-in-law. Mrs. (b)(6). I am a practicing physician from (b)(6) license number do. (b)(6) and licensed since (b)(6). I usually don't get involved with such a complaint. But in the years of practicing family practice, emergency medicine and now pain management. I am disappointed that this stool sample for collection was approved by the fda. This is a waste of time, money and medicare fraud. I do not like seeing money being wasted and this medical device for testing stool collection is ridiculous and wasteful. I have sent an email of complaint to the manufacturing company. (b)(4). Thank you for your review and reply to my complaint. Sincerely, (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074304
MDR Report Key7154567
Date Received2017-12-28
Date of Report2017-12-27
Date of Event2017-12-27
Date Added to Maude2017-12-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOC-AUTO FIT
Generic NameOC-AUTO FIT
Product CodeKHE
Date Received2017-12-28
Model NumberOC-AUTO FIT
Device Expiration Date2017-12-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPOLYMEDCO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-12-28

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