FDA Adverse Event Injury Summary report: N

ENDO POCKET 7.5X9"

MDR report key: 10470995 · Received August 31, 2020

Report

Report Number: 3007216334-2020-00377
Event Type: Injury
Date Received: August 31, 2020
Report Date: August 31, 2020
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Product Code: GCJ
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: TD
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEM, IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem · 1

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE SB979 WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. THE ISSUE WITH THE DEVICE WAS REPORTED AS "THIS SPECIMEN POUCH BURST DURING A PROCEDURE". THE REPORTER DID NOT HAVE ANY ASSESSMENT INFORMATION AVAILABLE FOR THIS COMPLAINT OTHER THAN IT OCCURRED. THE INFORMATION RECEIVED STATED THAT THE CASE WAS NOT COMPLETE; HOWEVER, A REASON WAS NOT GIVEN. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. ALSO, THERE WAS NO INFORMATION AVAILABLE FOR THE REMOVAL OF THE COMPONENTS OF THE DEVICE. THE OEM, UNIMAX MEDICAL SYSTEMS, HAS BEEN NOTIFIED OF THIS EVENT AND NO RESPONSE HAS BEEN RECEIVED. THE OEM HAS REPORTING RESPONSIBILITY FOR THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO NO KNOWLEDGE OF THE COMPONENTS BEING REMOVED FROM THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
938457	ENDO POCKET 7.5X9"	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	UNIMAX MEDICAL SYSTEMS, INC.		8251902166

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other