MAUDE Adverse Event Report: STOOL SAMPLE; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Device Problems False Negative Result (1225); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

I suspected i had worms because 2 people i was around suspected worms and 1 of them had four blood transfusions.I went to (b)(6) medical clinic in (b)(6) and was given the equipment to do a stool sample, ie.Plastic bowl, gloves container and bags.I was given medicine for worms before the results of the stool sample came back.I could clearly see eggs marbled in my poop.I had a histamine reaction 5 hours after taking the medicine.The stool sample came back negative.This is impossible because i could see the worm eggs clearly with the naked eye.My doctor is dr.(b)(6), d.O.In (b)(6) and the nurse practitioner who ordered the test is named (b)(6).There is no way this test should be negative.I could visually see the eggs.Dr.(b)(6) said i had a classic case of pinworms after i told him my symptoms and told him what i had been seeing in my stool.I was also treated in the emergency room at (b)(6) hospital on (b)(6) street in (b)(6).My friend mr.(b)(6) also gave a stool sample and was treated proactively for worms at (b)(6) regional hospital in (b)(6).I do not know the results of his stool sample.Company: unk to me, hospital knows.Fda safety report id# (b)(4).

• Brand Name: STOOL SAMPLE
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• MDR Report Key: 12161407
• MDR Text Key: 262027367
• Report Number: MW5102516
• Device Sequence Number: 1
• Product Code: NNK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 89