FDA Adverse Event Malfunction Summary report: N

BUTTERFLY EXPANDER FILL NEEDLE

MDR report key: 24764468 · Received April 1, 2026

Report

Report Number
MW5186291
Event Type
Malfunction
Date Received
April 1, 2026
Report Date
March 24, 2026
Manufacturer
UNKNOWN
Product Code
LCJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. ((B)(6) REF (B)(4). ALLEGED EVENT: SALES REPRESENTATIVE REPORTED "THOSE WHITE BUTTERFLY EXPANDER FILL NEEDLES ARE ABSOLUTELY TERRIBLE" OF A NON-ABBVIE DEVICE. THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICES STATUS IS UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
812368 BUTTERFLY EXPANDER FILL NEEDLE TISSUE EXPANDER AND ACCESSORIES LCJ UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown