CAREPOINT BY ALLISON MEDICAL CAREPOINT LUER LOCK SYRINGE WITH NEEDLE, 3ML 23 GAU

Report

• Report Number: MW5082208
• Event Type: Injury
• Date Received: December 17, 2018
• Date of Event: October 3, 2018
• Report Date: December 13, 2018
• Manufacturer: ALLSION MEDICAL INC
• Product Code: FMF
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Location: KY, US
• Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

THE SYRINGES AND NEEDLES THAT WERE USED FOR VACCINATIONS ARE CAUSING SORE CYSTIC NODULES THAT COME UP 3-4 WEEKS AFTER VACCINE ADMINISTRATION! DOSE OR AMOUNT: 3 MG/ML. DATES OF USE: (B)(6) 2018 - (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: VACCINE ADMINISTRATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1011962	CAREPOINT BY ALLISON MEDICAL CAREPOINT LUER LOCK SYRINGE WITH NEEDLE, 3ML 23 GAU	SYRINGE PISTON	FMF	ALLSION MEDICAL INC		70808
1011963	CAREPOINT BY ALLISON MEDICAL CAREPOINT LUER LOCK SYRINGE WITH NEEDLE, 3ML 23 GAU	NEEDLE, HYPODERMIC, SINGLE LUMEN	FMI	ALLISON MEDICAL INC		70808

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Other

Terms

Patient problem · 1

• Patient Problem/Medical Problem

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission