MAUDE Adverse Event Report: KCI USA, INC. KCI WOUND VAC FOAM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problem Break (1069)

Patient Problems Impaired Healing (2378); Foreign Body In Patient (2687)

Event Date 01/24/2023

Event Type  Injury  

Event Description

Patient had chronic non-healing abdominal wound from g-tube.Required i&d in september 2021 and wound vac from outside facility.Wound vac removed december 2021.She is overall remained stable, but has had ongoing issues with a chronic left sided abdominal wound, and ultimately was seen in clinic on (b)(6) 2023, with surgeon on (b)(6) 2023, patient was probed and foreign body removed from incision site of left side non-healing wound.The surgeon managed to fairly easily extract what he had initially thought was either a lap pad or a 4 x 4 sponge, but it turns out it is a rectangular piece of white kci wound vac foam.Obviously, it has been trimmed with a scissors and has a keyhole notch in it.It is a huge piece of material - 10 x 8 cm general dimensions and it is about 2 cm thick.Patient had a wound vac from september 2021-december 2021.Patient was a resident who received care at a local nursing home.

• Brand Name: KCI WOUND VAC FOAM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.
• MDR Report Key: 16399420
• MDR Text Key: 309905532
• Report Number: MW5115033
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White