CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

Report

• Report Number: 1226348-2015-10778
• Event Type: Injury
• Date Received: December 30, 2015
• Manufacturer: CODMAN & SHURTLEFF, INC. / MEDOS S.A.
• Product Code: JXG
• PMA / PMN Number: PK954021
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: TX, US
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

Description of Event or Problem · 1

TWO (2) EACH 82-1749 CATHETERS FAILED ALONG WITH 1 EACH EDS 3 DRAIN 82-1731. THE PATIENT GOT AN INFECTION WHILE USING OUR PRODUCT AND WOULD LIKE THE PRODUCTS REPLACED. THEY WERE DISCARDED BEFORE I COULD GET LOT NUMBERS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
859435	CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH	SHUNT, CENTRAL NERVOUS SYSTEM & COMPS	JXG	CODMAN & SHURTLEFF, INC. / MEDOS S.A.		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	82-1749

Terms

Patient problem · 1

• Unspecified Infection

Product problems · 1

• Use of Device Problem

Source type · 1

• COMPANY REPRESENTATIVE