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

Model Number UNKVAC

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Bowel Perforation (2668)

Event Date 01/01/2000

Event Type  Injury  

Manufacturer Narrative

Other (code unspecified) - device identifiers not provided.Based on information provided, it cannot be determined that the alleged mesh tear and subsequent infection is related to v.A.C.® therapy.It is unknown if medical or surgical intervention was required, or if the patient was on a kci product at time of the alleged adverse events.A review of kci records noted this patient utilized the barimax¿ ii hospital bed from (b)(6) 2007 time frame with no other kci product placements located.There have been several attempts made to gather additional information, but there has been no response.Device labeling, available in print and online, states: warnings protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Always ensure that v.A.C.® foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, bio-engineered tissue or multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.Consideration should also be given to the negative pressure setting and therapy mode when used when initiating therapy.Contraindications -do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs or nerves.Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals and instillation therapy parameters (for the v.A.C.Instill® therapy system).Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.

Event Description

On dec 14 2017, the following information was obtained via review of social media account by kci representative from account holder: ¿i had something similar in 2000.Mine was on my abdomen and around the size of a dinner plate.It worked great for a while but it sucked intestines against the mesh trying to hold me together.They attached themselves to the mesh and then tore.I ended up with feces all over my abdominal cavity.Major infection.¿ the patient alleged she nearly ¿died.¿ no additional information is available.The unit¿s type or serial number was not provided, therefore kci cannot conduct a device evaluation of the unit.

• Brand Name: V.A.C.® THERAPY
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX
• MDR Report Key: 7186328
• MDR Text Key: 97110085
• Report Number: 3009897021-2018-00002
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other