CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED ONE (1) SAMPLE RECEIVED NOT DECONTAMINATED WITHOUT ITS ORIGINAL PACKAGING. THE REPORTED ISSUE WAS NOT CONFIRMED. THE REPORT OF UNUSUAL ODOR WAS NOT NOTICE. NO FAULT WAS FOUND. UNIQUE IDENTIFIER AND G5 ARE UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. OPERATOR OF DEVICE IS PATIENT/CONSUMER. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE PRODUCT GAVE OFF AN UNUSUAL ODOR (THE PRODUCT SMELLED FISHY). NO PATIENT INJURY WAS REPORTED.