MAUDE Adverse Event Report: PHARMCHEM, INC. PHARMCHEK SWEAT PATCH; CONTAINER, SPECIMEN, STERILE

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 05/12/2018

Event Type  Injury  

Event Description

False positive of sweat patch by pharmchem.State seizure of children.Case plan required by state until proof no safety risk or drug use.Fda safety report id# (b)(4).

• Brand Name: PHARMCHEK SWEAT PATCH
• Type of Device: CONTAINER, SPECIMEN, STERILE
• Manufacturer (Section D): PHARMCHEM, INC.
• MDR Report Key: 8541181
• MDR Text Key: 142957304
• Report Number: MW5086068
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• 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; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 80