MAUDE Adverse Event Report: MDF INSTRUMENTS CRAFTECH LLC MDF; BABINSKI REFLEX HAMMER WITH POINTED TIP

Model Number	MDF535
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer service will contact the customer by amazon buyer messages and request the serial number, lot number, or a picture of the instrument.This information is needed for shanghai to begin a record review for this non-conformance.
Event or Problem Description
It was reported: "pointed tip was uneven and caused unintended skin irritation rather than eliciting precise reflex responses.".

• Brand Name: MDF
• Common Device Name: BABINSKI REFLEX HAMMER WITH POINTED TIP
• Manufacturer (Section D): MDF INSTRUMENTS CRAFTECH LLC; road 115 km 12.6 barrio pueblo; rincon, pr 00677 ; * 00677
• Manufacturer (Section G): MDF INSTRUMENTS CRAFTECH LLC; road 115 km 12.6 barrio pueblo; rincon, pr 00677 ; * 00677
• Manufacturer Contact: marisol rodriguez ; road 115 km 12.6 barrio pueblo; rincon, pr 00677 ; * 00677
• MDR Report Key: 22923320
• Report Number: 3015989011-2025-00009
• Device Sequence Number: 21118200
• Product Code: FZY
• UDI-Device Identifier: 06940211613016
• UDI-Public: 6940211613016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: MDF535
• Device Catalogue Number: MDF53511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female