FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 5366204 · Received January 14, 2016

Report

Report Number: 3002808486-2016-00014
Event Type: Injury
Date Received: January 14, 2016
Report Date: March 22, 2018
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2016032. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

Additional Manufacturer Narrative · 1

(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS EITHER GUNTHER TULIP MREYE, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER, OR COOK CELECT PLATINUM. LOT# UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. AS CATALOG# IS UNKNOWN IT COULD BE EITHER K000855, K032426, K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

Description of Event or Problem · 1

DESCRIPTION ACCORDING TO COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED AN IVC FILTER" PATIENT OUTCOME: IT IS ALLEGED "[PT] SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAS LOST ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE." HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
24727	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening