FDA Adverse Event Other Summary report: N

CODMAN DISPOS PERFORATOR

MDR report key: 795151 · Received December 1, 2006

Report

Report Number: 1226348-2006-00358
Event Type: Other
Date Received: December 1, 2006
Date of Event: October 30, 2006
Manufacturer: CODMAN & SHURTLEFF, INC.
Product Code: HBE
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

IT DOES NOT APPEAR THAT THE DEVICE IS AVAILABLE FOR EVALUATION. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED FOR THE PERFORATOR AND THEY CONFIRMED THAT THE DEVICE CONFORMED TO TESTING/MANUFACTURING SPECIFICATIONS. THE LOT RECORDS WERE NOT AVAILABLE FOR THE AIR DRIVER DUE TO THE AGE OF THE DEVICE. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

Description of Event or Problem · 1

AFFILATE REPORTED THAT THE PATIENT DIED OF AN EMBOLISM DURING DRILLING WITH DISPOSABLE PERFORATOR AND THE POWER AIR DRIVER UNIT. THE DOCTOR COMMENTED THAT THE CAUSE OF THE AIR EMBOLISM WAS NOT CLEAR. ALSO SAID, THE DEVICES WERE NOT INVOLVED IN THIS OCCURRENCE BECAUSE HE DID NOT FINISH MAKING THE BURR HOLE. THE DEVICES WERE NOT RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CODMAN DISPOS PERFORATOR	DRILLS, BURRS, TREPHINES & ACC	HBE	CODMAN & SHURTLEFF, INC.	NA	JY844

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other