MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING; OMP

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The abthera¿ sensat.R.A.C.¿ open abdomen dressing lot number 60296970v003 was invalid and the product was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on information provided, kci cannot determine when the foreign body alleged to be the abthera¿ sensat.R.A.C.¿ open abdomen dressing was placed in the wound.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.This event is being reported due to potential use error.Device labeling, available in print and online, states: dressing removal: the dressing components are not bioabsorbable.Always remove all dressing components from the abdomen at every dressing change.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

Event Description

On (04-may-2022, the following information was reviewed by kci on the fda maude database via report number (b)(4): on (b)(6) 2020, "patient presented to the or (operating room) for abthera wound vac device application.During this procedure, pieces of the [foreign material alleged to be] abthera sponge were allegedly left inside the patient's abdomen.Post-op imaging was completed but did not identify the retained sponges because they are not radiopaque.Less than two weeks later, patient came in for elective abdominal surgery and the two retained sponges were identified." no additional information was provided.The abthera¿ sensat.R.A.C.¿ open abdomen dressing lot number 60296970v003 was invalid, and the product was not returned; therefore, a device history record review and a device evaluation could not be performed.

• Brand Name: ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 14498429
• MDR Text Key: 293880501
• Report Number: 3009897021-2022-00100
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Catalogue Number: M8275026
• Device Lot Number: 60296970V003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention