MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD NIPRO HYPODERMIC NEEDLE

Model Number	AH+3013-1M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Four patients developed rashes following glp-1 medication injections administered for the treatment of obesity.None of the patients had a history of known allergies, and no injuries, medical interventions, or hospitalizations were required as a result of the reactions.The facility subsequently switched to a different lot of the product.All affected patients recovered fully, and the used product was discarded by the facility.
Additional Manufacturer Narrative
Final investigation report attached is on retained unused samples only.
Event or Problem Description
Four patients developed rashes following glp-1 medication injections administered for the treatment of obesity.None of the patients had a history of known allergies, and no injuries, medical interventions, or hospitalizations were required as a result of the reactions.The facility subsequently switched to a different lot of the product.All affected patients recovered fully, and the used product was discarded by the facility.

• Brand Name: NIPRO HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 23258273
• Report Number: 8041145-2025-00008
• Device Sequence Number: 21094008
• Product Code: FMI
• UDI-Device Identifier: 00383790002141
• UDI-Public: 00383790002141
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: AH+3013-1M
• Device Lot Number: 24F10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown