MAUDE Adverse Event Report: BIO-SIGNAL GROUP CORP. HYDRODOT; DEGREASER, SKIN, SURGICAL

Model Number 1700-24

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

Waveprep eeg skin prep solution arrived dried out, consistency of the skin prep solution is thick, dry, and not in a state that could be used.Product is typically in a liquid gel form that can be easily applied to the skin, the product we received was dried out and not usable.Manufacturer response for electrode skin prep waveprep 1700-24, mvap (per site reporter).We will report this to the manufacturer and request credit.

• Brand Name: HYDRODOT
• Type of Device: DEGREASER, SKIN, SURGICAL
• Manufacturer (Section D): BIO-SIGNAL GROUP CORP.; 3 post office square; suite k; acton MA 01720
• MDR Report Key: 16408299
• MDR Text Key: 309881519
• Report Number: 16408299
• Device Sequence Number: 1
• Product Code: KOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2023

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
• Device Model Number: 1700-24
• Device Catalogue Number: 016-402900
• Device Lot Number: 220310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1