FDA Adverse Event Summary report: N

SURGIMEND

MDR report key: 1899031 · Received October 26, 2010

Report

Report Number: 3004170064-2010-00013
Date Received: October 26, 2010
Report Date: October 26, 2010
Manufacturer: TEI BIOSCIENCES, INC.
Product Code: FTM
PMA / PMN Number: 071807
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURING LOT FOR THE DEVICE WAS REVIEWED. NOTHING UNUSUAL WAS NOTED. THE EXPLANTED DEVICES WERE NOT RETURNED TO THE MANUFACTURER AND COULD NOT BE EVALUATED. THE DEVICE UNDERGOES TERMINAL STERILIZATION VIA A VALIDATED PROCESS. IT IS UNLIKELY THE INFECTION ORIGINATED WITH THE DEVICE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED REGARDING THIS PRODUCT LOT.

Description of Event or Problem · 1

A (B)(6) FEMALE PT, (B)(6), UNDERWENT SURGICAL REMOVAL OF HER RIGHT BREAST FOR CANCER. THE LEFT BREAST WAS ALSO REMOVED PROPHYLACTICALLY. THE DATE OF THE SURGERY IS UNK. THE PT WAS GIVEN ANTIBIOTIC MEDICATION BEFORE, DURING AND AFTER HER SURGICAL PROCEDURES. TISSUE EXPANDERS WERE IMPLANTED DURING THE PROCEDURE AS WAS THE DEVICE, SURGIMEND. TWO DEVICES WERE IMPLANTED, ONE AT EACH SURGICAL SITE. THE PRODUCT LOT NUMBER FOR EACH DEVICE WAS 1004005 WITH AN EXPIRATION DATE OF 12/31/2012. DRAINS WERE ALSO USED AND WERE IN PLACE FOR 7-9 DAYS. APPROXIMATELY 22 DAYS FOLLOWING THE SURGERY, AN INFECTION WAS NOTED AT EACH SURGICAL SITE. THE INFECTION WAS IDENTIFIED AS GRAM NEGATIVE BACTERIA. IT WAS IDENTIFIED AS KLEBSIELLA. AT THAT TIME, ADDITIONAL SURGERY WAS PERFORMED. BOTH THE TISSUE EXPANDERS AND THE SURGIMEND IMPLANTS WERE REMOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SURGIMEND	SURGICAL MESH	FTM	TEI BIOSCIENCES, INC.	606-001-006	1004005

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Required Intervention