FDA Adverse Event Malfunction Summary report: N

SPECIMEN RETRIEVAL BAG

MDR report key: 10335740 · Received July 28, 2020

Report

Report Number: 3002590791-2020-00080
Event Type: Malfunction
Date Received: July 28, 2020
Report Date: July 28, 2020
Manufacturer: GENICON, INC.
Product Code: GCJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 1

THE INCIDENT REPORT STATED THAT THE NUMBER OF OCCURRENCES WAS 2.0 (CORRESPONDING GENICON, INC. COMPLAINT # IS (B)(4). MEDWATCH REPORT 3002590791-2020-00078 WAS SUBMITTED FOR THE FIRST DEVICE/OCCURRENCE. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE SECOND DEVICE/OCCURRENCE. THE INCIDENT REPORT WAS REPORTED BY HEALTHTRUST TO GENICON'S DISTRIBUTOR PROGRESSIVE MEDICAL, INC. ON (B)(6) 2020, AND THEN PROGRESSIVE MEDICAL, INC. REPRESENTATIVE FORWARDED IT TO GENICON, INC. ON (B)(6) 2020. PROGRESSIVE MEDICAL, INC. HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE FOLLOWING DATES: (B)(6) 2020. NO DEVICES HAVE BEEN RETURNED TO GENICON, INC. FOR EVALUATION FOR EITHER ALLEGED OCCURRENCE. IN ADDITION, NO PHOTOGRAPHS WERE PROVIDED.

Description of Event or Problem · 1

"THE BAG TORE DURING REMOVAL. THIS IS THE SECOND INSTANCE. REPORTED TO VENDOR REPRESENTATIVE. REPORTING PURPOSES ONLY." PLEASE NOTE: THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION. AFTER MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION, WE HAVE NO PRODUCT DETAILS, NO PATIENT STATUS, AND WE DON'T KNOW THE DATE OF OCCURRENCE OF THE ALLEGED INCIDENT. THE DISTRIBUTOR SPOKE TO THE FACILITY CONTACT WHO COULD NOT CONFIRM THAT THE DEVICE INVOLVED WAS A GENICON PRODUCT. THE REPORT WILL BE UPDATED WITH ADDITIONAL INFORMATION IF IT BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
800536		SPECIMEN RETRIEVAL BAG	GCJ	GENICON, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1