MAUDE Adverse Event Report: KCI USA, INC. ABTHERA DRESSING; MESH, SURGICAL, POLYMERIC

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2021

Event Type  malfunction  

Event Description

Abthera dressing was placed and patient was transferred.Transferring facility reported that 5 pieces of blue sponge alleging to be the abthera dressing was found in patients wound.Undetermined.Fda safety report id # (b)(4).

• Brand Name: ABTHERA DRESSING
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): KCI USA, INC.
• MDR Report Key: 12280821
• MDR Text Key: 265431781
• Report Number: MW5103022
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR