MAUDE Adverse Event Report: GENICON, INC.; SPECIMEN RETRIEVAL BAG

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The incident report stated that the number of occurrences was 2.0.Manufacturer's report is for the first device (occurrence).A separate medwatch report will be 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.

Event Description

"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.

• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10335737
• MDR Text Key: 204763074
• Report Number: 3002590791-2020-00079
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1