MAUDE Adverse Event Report: PENCOED REAGENT MANUFACTURING 5,1 FS QUICK REF GUIDE GREEK; CONDUCTION NEEDLE KIT

Model Number 6802112

Device Problems Device Appears to Trigger Rejection (1524); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Cognitive Changes (2551)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

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• Brand Name: 5,1 FS QUICK REF GUIDE GREEK
• Type of Device: CONDUCTION NEEDLE KIT
• Manufacturer (Section D): PENCOED REAGENT MANUFACTURING; felindre meadows pencoed, bridgend, wales, cf35 5pz; UK
• Manufacturer (Section G): PENCOED REAGENT MANUFACTURING; felindre meadows pencoed, bridgend, wales, cf35 5pz; UK
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18592648
• MDR Text Key: 334641337
• Report Number: 3007111389-2024-70675
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 01/23/2024

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?: No
• Device Expiration Date: 01/21/2024
• Device Model Number: 6802112
• Device Catalogue Number: 6802112
• Device Lot Number: 1234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/27/2024
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Race: Asian