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 |