MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C.® THERAPY SYSTEM; OMP

Model Number UNKVAC

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

Patient Problem Tissue Damage (2104)

Event Date 08/01/2007

Event Type  Injury  

Manufacturer Narrative

Date of event: the specific date of event was not provided.The study included patients who between august 2007 and december 2015.Other (code unspecified): device identifier was not provided.Based on information provided, it cannot be determined that the alleged flap revisions are related to v.A.C.® therapy.There have been several attempts made to gather additional clinical and device information, but there has been no response.The article noted under outcomes: "there was an equivalent risk of eschar formation, flap necrosis, fat necrosis, flap revision, flap dehiscence, and secondary amputation regardless of npwt or antibiotic bead utilization.There was no significant association between use of npwt and infection rate.Use of npwt was associated with a significantly increased rate of complications." device labeling, available in print and online, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.[ref id (b)(4)].

Event Description

On 10-dec-2019, the following information was received by kci after a review of journal article, the efficacy of negative pressure wound therapy and antibiotic beads in lower extremity salvage.Doi:10.1016/j.Jss.2019.09.055.That noted the following under table 4: 'injury and surgical complications': 4 patients underwent flap revision while on npwt [negative-pressure wound therapy].The article noted under outcomes: "there was an equivalent risk of eschar formation, flap necrosis, fat necrosis, flap revision, flap dehiscence, and secondary amputation regardless of npwt or antibiotic bead utilization.Use of npwt was associated with a significantly increased rate of complications." it was also noted: "as this study was a retrospective review of patients with traumatic lower extremity open fractures who received npwt or antibiotic beads before soft tissue reconstruction, we cannot definitely determine causality in the relationship between antibiotic bead use and infection rate, npwt use and complication rate, or development of infection and delay in closure." no additional information.The v.A.C.® therapy system type and device identifiers were not provided, therefore a device evaluation could not be performed.

• Brand Name: V.A.C.® THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; 6203 farinon drive; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 9573442
• MDR Text Key: 176012668
• Report Number: 3009897021-2020-00019
• 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: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

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: UNKVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention