FDA Adverse Event Injury Summary report: N

GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET

MDR report key: 6313676 · Received February 9, 2017

Report

Report Number: 3002808486-2017-00404
Event Type: Injury
Date Received: February 9, 2017
Report Date: May 24, 2017
Manufacturer: COOK INC
Product Code: DTK
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K090140, K112119 OR K121057. (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. (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K090140, K112119 OR K121057. (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).

Description of Event or Problem · 1

DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2015¿. PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
100173	GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	COOK INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening