MAUDE Adverse Event Report: SOUTHMEDIC INC. ABRA ABDOMINAL WALL CLOSURE SET

Model Number CWK08

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

Based on the complaint description, it appears that there was patient bowel injury that was possibly attributed to the abra abdominal device in conjunction with another device, kci's abthera.However, the abra abdominal device performed as expected and there was no product malfunction.The bowel injury was likely off label use due to user error, but because injury occurred, southmedic has chosen to report the event.The physician believes that the suction forces from the wound vac had funneled through the elastomer retainer causing it to suction the small intestine, which over time may have caused the bowel leak.The instructions for use for the abthera device details the need to use a visceral protective layer, covering all exposed viscera during use.The abra abdominal instructions for use detail the need to use the southmedic surgical retainer to provide visceral protection.The abra abdominal ifu also includes the instruction to trim the elastomer retainer to match the wound length, which would ensure that the elastomer retainer would not overhang beyond the surgical retainer, as the surgical retainer is intended to extend beyond the insertion points.The surgical retainer would act as a barrier between the elastomer retainer and abdominal contents.

Event Description

The case was for a male patient, (b)(6) years of age who had an abra device installed.On (b)(6) 2020 abra abdominal was successfully installed in the patient (defect size 25-26cm width entire length of torso).At the subsequent wound vac changes the patient and device both looked well, by (b)(6) the abdominal defect measured under 5cm.On (b)(6) 2020 the patient was reportedly suffering from other complications related to their initial trauma and had to go on dialysis, abra was placed on reduced 1 x tension to prevent the defect from retracting again.On (b)(6) 2020 the open abdomen defect had grown in the intervening time, and the abra system was placed under normal tension again to facilitate a primary closure.On (b)(6) 2020 a bowel leak was discovered and it was reported that a loop of small intestine had worked its way over the surgical retainer and against the end of the elastomer retainer.It was believed that suction forces from the wound vac had funneled through the elastomer retainer causing it to suck against the small intestine and over time this caused a small bowel leak.The abra device was removed, the bowel leak repaired and the patient was undergoing washouts with abthera before another attempt at closure was made.The surgeon would likely bridge the remaining fascial defect with a mesh and raise skin flaps to provide a primary skin closure.The surgeon believed abra was removed not due to any complication secondary to the abra but rather secondary to patient medical issues.The surgeon did think that abra's presence, in conjunction with other factors, caused this situation.

• Brand Name: ABRA ABDOMINAL WALL CLOSURE SET
• Type of Device: ABDOMINAL WALL CLOSURE SET
• Manufacturer (Section D): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: tish whitehead ; 50 alliance blvd.; barrie, ontario L4M 5-K3 ; CA L4M 5K3
• MDR Report Key: 10689672
• MDR Text Key: 212474729
• Report Number: 8022032-2020-00003
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: CWK08
• Device Catalogue Number: CWK08
• Device Lot Number: W67803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 34 YR