FDA Adverse Event Injury Summary report: N

VAC ATS

MDR report key: 4619380 · Received March 19, 2015

Report

Report Number: 3009897021-2015-00016
Event Type: Injury
Date Received: March 19, 2015
Report Date: February 18, 2015
Manufacturer: KCI USA INC.
Product Code: OMP
PMA / PMN Number: K062227
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LO
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PT'S INCLUDED IN THE STUDY WERE TREATED WITH NEGATIVE PRESSURE WOUND THERAPY FROM 2000 TO 2011. IT WAS UNK WHEN THE EVENTS OCCURRED AS THIS INFO HAS NOT BEEN PROVIDED. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FISTULAS ARE RELATED TO VAC THERAPY. THERE HAVE BEEN SEVERAL UNSUCCESSFUL ATTEMPTS MADE THE GATHER ADD'L INFO.

Description of Event or Problem · 1

ON (B)(6) 2015, KCI REC'D ARTICLE, HUTAN M JR, ET AL. USE OF INTRAABDOMINAL VAC (VACUUM ASSISTED CLOSURE) LOWERS MORTALITY AND MORBIDITY IN PT WITH OPEN ABDOMEN. BRATISL LEK LISTY. 2013; 114 (8). 451-454. DOI: 10.4149/BLL_2013_094 THAT REPORTED THE FOLLOWING: "OUR AIM WAS TO COMPARE TWO GROUPS OF PTS WITH OA [OPEN ABDOMEN], NAMELY ONE MANAGED BY KERN LAPAROSTOMY, THE OTHER BY INTRAABDOMINAL VAC AND TO STATISTICALLY EVALUATE THEIR OUTCOMES IN TERMS OF MORTALITY, CLOSURE OF ABDOMINAL CAVITY, INCIDENCE OF ENTEROATMOSPHERIC FISTULAS, POSSIBILITY OF THEIR PRIMARY CLOSURE, AS WELL AS THE POSSIBILITY OF DIVERTING THE ENTERAL CONTENT FROM FISTULAS." BASED ON THE REVIEW OF THE INFORMATION PROVIDED FROM THE STUDY, 9 PTS (TABLE 4, PG 453 PER THE ATTACHED ARTICLE) DEVELOPED ENTEROATMOSPHERIC FISTULAS WHILE USING VAC ATS AND VAC GRANUFOAM AND/OR WHITEFOAM DRESSING. NO ADD'L INFO IS AVAILABLE. THE UNIT'S SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
187607	VAC ATS		OMP	KCI USA INC.	WNDATS

Patients

Seq	Age	Sex	Outcome	Treatment
1