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

Model Number NOT PROVIDED BY DHS WORKER

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/1986

Event Type  Injury  

Event Description

False positive believed from environmental contamination.Resulted dhs / state seizing custody of children.No other positive was recorded when other types of drug testing of ua and hair testing was conducted.Numerous ua's and overlapping hair tests documents otherwise from contained no illegal drug or "positive" results months prior and months after the false positive with pharmachem's sweat patch.Fraying around edges was seen in after about two weeks of wear.Dhs worker was non-trained in any health education or training.Please note the patch was worn 14 days from date given for test date.Subject was required to enter a "case plan" with dhs to "work towards" eliminating alleged substance use disorder and / or safety risk determined because of the false positive, as well as numerous therapy sessions, which is why "hospitalization" was included in adverse event.Custody of 3 children continues with dhs with "visits" granted to subject.No other signs or symptoms of ny substance use disorder whatsoever.Subject was required to wear the sweat patch test as only "routine" and not for probable cause and / or suspicion.Patch test worn exactly 14 days until (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: PHARNCHEK SWEAT PATCH
• Type of Device: CONTAINER, SPECIMEN, STERILE
• Manufacturer (Section D): PHARMCHEM, INC.
• MDR Report Key: 8540749
• MDR Text Key: 142875161
• Report Number: MW5086051
• Device Sequence Number: 0
• Product Code: FMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2021
• Device Model Number: NOT PROVIDED BY DHS WORKER
• Device Catalogue Number: NOT PROVIDED BY DHS WORKER
• Device Lot Number: NOT PROVIDED BY DHS WORKER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 36 YR
• Patient Weight: 66