FDA Adverse Event Injury Summary report: N

TIMESH

MDR report key: 1422945 · Received July 27, 2009

Report

Report Number: 3003936139-2009-00002
Event Type: Injury
Date Received: July 27, 2009
Report Date: July 27, 2009
Manufacturer: GFE MEDIZINTECHNIK GMBH
Product Code: FTL
PMA / PMN Number: K031225
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

IT WAS RECENTLY DISCOVERED THAT THIS CASE HAS NOT BEEN APPROPRIATELY REPORTED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED IMMEDIATELY AFTER THE RECEIPT OF THE MESSAGE (DATED 2007); THE BATCH MET ALL CRITERIA FOR THE RELEASE OF FINISHED PRODUCTS. A SECOND REVIEW OF THE DHR AND RETAINED SAMPLES WERE CARRIED OUT PRIOR TO THIS MDE (SEE ANNEX 1). CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL FORM WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem · 1

INFORMATION RECEIVED: PROCEDURE: THEN A PIECE OF TI MESH WAS USED; IT WAS CUT TO SIZE AT 30 X 10 CM, AND SUTURED TO THE FASCIA WITH INTERRUPTED HORIZONTAL MATTRESS SUTURES USING 2-0 ETHIBOND. OUTCOME: MESH TORN LOOSE. THERE WAS MESH PRESENT. THIS WAS CAREFULLY CUT AND EXTENDED SUPERIORLY AND INFERIORLY AND DISSECTION WAS CARRIED AROUND THE BOWEL AND INTO THE ABDOMINAL CAVITY. AFTER THIS HAS BEEN DONE, THE EDGES WERE FREED OF THE MESH. THE PATIENT HAD THE DILATED BOWEL CAREFULLY BROUGHT FORTH. THERE WAS AN OBSTRUCTED AREA IN THE RIGHT LOWER QUADRANT, WHICH WENT TO THE ANTERIOR ABDOMINAL WALL. THE PATIENT THEN HAD THE MESH REATTACHED TO THE FASCIA ON THE LEFT SIDE WHERE IT HAD TORN LOOSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TIMESH	SURGICAL MESH, FTL	FTL	GFE MEDIZINTECHNIK GMBH	6000139	11894

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization