MalfunctionFEN

PUMP ON THE URODYNAMIC STUDY SYSTEM - UDS

Received Dec 26, 2024

Report MW5163950 · MDR key 21020181

Device

Generic name

Device, Cystometric, Hydraulic

Manufacturer

Laborie Medical Technologies Corp.

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED. CALLER REPORTED THE PUMP ON THE UDS MACHINE WAS BROKEN. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5163951.