MAUDE Adverse Event Report: CURATIVE, INC. CURATIVE; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Event Description

Took test with curative.Never received results or correspondence.This was in (b)(6) curative remote test site.Fda safety report id # (b)(4).

• Brand Name: CURATIVE
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• Manufacturer (Section D): CURATIVE, INC.
• MDR Report Key: 12203411
• MDR Text Key: 262945045
• Report Number: MW5102665
• Device Sequence Number: 1
• Product Code: NNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR