MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ABTHERA OPEN ABDOMEN DRESSING; OMP

Model Number VACDSP

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

The abthera¿ dressing identifier was not available and the dressing 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¿ dressing was placed in the wound.It is unknown if and what medical or surgical intervention was required related to the alleged event.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.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.

Event Description

On 07-sep-2021, the following information was provided to kci by the fda via medwatch report mw5103022: on (b)(6) 2021, "[foreign material alleged to be] abthera dressing was placed and patient was transferred.Transferring facility reported that 5 pieces of a blue sponge alleging to be the abthera dressing was found in patient's wound.Undetermined." no additional information was provided.The abthera¿ open abdomen dressing lot number was not provided, and the product was not returned; therefore, a device history record review and a device evaluation could not be performed.

• Brand Name: ABTHERA 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: 12573735
• MDR Text Key: 274985889
• Report Number: 3009897021-2021-00240
• 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: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/04/2021
• 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): Other