MAUDE Adverse Event Report: FORWARD SCIENCE LLC / FORWARD SCIENCE TECHNOLOGIES LLC SALIVAMAX; SALIVA, ARTIFICIAL

Lot Number	13147
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This product consists of small packets of a free flowing powder.I noticed several packets that were swollen and the powder had crystalized within the packet.This is meant to be rehydrated and used as a mouth rinse.I did not use any of the crystalized product and called the company to report it.They told me it was probably just water and/or air that got in the product packet and it would be fine to use but i do not feel safe using it.This didn't seem to be a satisfactory explanation.Fda safety report id# (b)(4).

• Brand Name: SALIVAMAX
• Common Device Name: SALIVA, ARTIFICIAL
• Manufacturer (Section D): FORWARD SCIENCE LLC / FORWARD SCIENCE TECHNOLOGIES LLC
• MDR Report Key: 11222640
• Report Number: MW5098958
• Device Sequence Number: 4017791
• Product Code: LFD
• UDI-Device Identifier: 00370275629047
• UDI-Public: (01)00370275629047(17)2110
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/08/2021
• Device Lot Number: 13147
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 118