ABRA ABDOMINAL WALL CLOSURE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-16 for ABRA ABDOMINAL WALL CLOSURE * manufactured by *.

Event Text Entries

[3896645] The patient is critically ill with gunshot wounds to the abdomen with an open abdomen. Current treatment methods for wound closure weren't working so the surgeon requested a specific device, the abra dynamic wound closure system, which was new to this facility. Surgery purchasing staff quickly researched the product, contacted the company and arranged for a representative to come to the facility the day of the procedure. Surgery leadership approved the use of the product. The surgeon applied the abra system according to the manufacturer's instructions. The manufacturer's rep was present for the procedure per the request of the facility's buyer. There was no communication given to the unit nurses prior to the procedure regarding the abra. After the case, the rep. Went to the critical care unit where the patient was transferred and conducted a short in-service for staff on the new device. The first day after the abra was placed; the wound ostomy care (woc) nurse was consulted for pressure ulcer prevention related to the abra device. Nursing demonstrated release of tension for cleansing under the button anchors and for inspection. The duration of the abra system application was one week. The day prior to removal, an enterocutaneous fistula presented. The surgeon indicated the abdomen overall was fast becoming a frozen abdomen. The abra device was removed and an abthera device was placed. The first day after removal of the abra, the woc nurse was consulted regarding multiple "holes" (puncture sites). The woc nurse noted: 1. Right side of incision puncture sites are superficial and primarily dry. 2. Left side distal to tube feeding with a few areas of depth and yellow slough with serious exudate. The woc nurse recommended calcium alginate to distal left puncture sites that have depth and then to cover weepy areas on each side with strip of foam non-adhesive and minimal medipore tape every other day. Padding with foam under disk of tube feeding advised to reduce further risk of pressure. Five days later, the woc nurse was consulted and two areas of concern for pressure ulcers were identified. The first was the skin underneath the peg tube (the tube was removed the evening prior) and nursing noted unstageable slough-covered ulcerations in a circular pattern under the disc. The peg was completely concealed by the abra. The peg was placed based on the patient's anatomy so there were no other options. The second ulceration was located more proximally on the right side and just medial to a puncture site. This was assessed as a stage iii ulcer. Woc gave recommendations on care. With the removal of the abra, there were no longer pressure concerns to these areas and the pressure ulcers healed. The device's post-operative nursing care instructions state the following: "if an ulcer is detected under the button anchor: reduce elastomer tension at that anchor and add padding under the anchor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3436478
MDR Report Key3436478
Date Received2013-10-16
Date of Report2013-09-30
Date of Event2013-08-19
Report Date2013-09-30
Date Reported to FDA2013-10-16
Date Reported to Mfgr2013-10-30
Date Added to Maude2013-10-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameABRA ABDOMINAL WALL CLOSURE
Generic NameRETENTION DEVICE, SUTURE
Product CodeKGS
Date Received2013-10-16
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age1 DA
Device Sequence No1
Device Event Key0
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2013-10-16

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