FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 6224403 · Received January 5, 2017

Report

Report Number: 3002808486-2016-01590
Event Type: Injury
Date Received: January 5, 2017
Report Date: December 22, 2016
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS. (B)(4).

Additional Manufacturer Narrative · 1

MANUFACTURER REF# (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. 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.

Description of Event or Problem · 1

DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED. IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT FILTER ON (B)(6) 2015". IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

Description of Event or Problem · 1

DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
7497	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening