FDA Adverse Event Injury Summary report: N

PROLENE POLYPROPYLENE SUTURE

MDR report key: 1910354 · Received November 24, 2010

Report

Report Number: 2210968-2010-01588
Event Type: Injury
Date Received: November 24, 2010
Date of Event: October 1, 2010
Report Date: October 25, 2010
Manufacturer: ETHICON, INC.
Product Code: GAW
PMA / PMN Number: N16374
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFO: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH ZPE830 MFG DATE: 12/01/2007, EXP DATE: 01/31/2012; BATCH CAB150 MFG DATE: 01/01/2010, EXP DATE: 01/31/2015; BATCH AKB904 MFG DATE: 09/01/2008, EXP DATE: 07/31/2013; BATCH AKE378 MFG DATE: 09/01/2008, EXP DATE: 07/31/2013. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PT UNDERWENT AN ATRIAL SEPTAL DEFECT PROCEDURE WITH A PERICARDIAL PATCH IN (B)(6) 2010 AND SUTURE WAS USED. THE SURGEON SUTURED THE PATCH TO THE SEPTUM TO CLOSE THE COMMUNICATION BETWEEN BOTH ATRIUMS. WHEN THE SURGERY WAS COMPLETE AND THE PT WAS IN THE ICU, THE PT HAD TO BE REOPERATED ON BECAUSE, THE KNOT UNTIED AND THE PATCH WAS NO LONGER SUTURED. THE PT HAD TO GO ON THE PUMP AGAIN AND SURGERY WAS STARTED AGAIN. THE KNOT IS SQUARE WITH ONE HAND AND THE SUTURE IS CONTINUOUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROLENE POLYPROPYLENE SUTURE	SUTURE, NON-ABSORBABLE	GAW	ETHICON, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention