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

Model Number WNDACT

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

The device type and identifier were not provided.Based on the information provided, it cannot be determined that the alleged injuries and subsequent surgeries are related to the v.A.C.® therapy system.The patient had been hospitalized for 27 days and had recently underwent a revision tangential excision with graft surgery three days prior.To date, kci has located no record of a kci-manufactured mobile negative pressure device being provided to the plaintiff-patient.Consequently, kci cannot presently confirm the plaintiffs' allegation that a kci-manufactured mobile negative pressure device was provided to the plaintiff-patient, nor can a device evaluation be performed.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.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.Pain management patients receiving v.A.C.® therapy may experience a reduction in pain as the wound begins to heal.However, some patients experience discomfort during treatment or dressing changes.In line with institutional guidelines, a validated pain scoring tool should be used, and pain scores should be discontinued where appropriate before, during and after dressing-related procedures.In addition, the following strategies should be considered: if the patient complains of discomfort throughout therapy, consider changing to v.A.C.® whitefoam dressing.Ensure the patient receives adequate analgesia during treatment.If the patient complains of discomfort during the dressing change, consider premedication, the use of a non-adherent layer before foam placement, using v.A.C.® whitefoam to dress the wound, or managing the discomfort as prescribed by the treating physician.A sudden increase or change in the character of the pain requires investigation.

Event Description

On 29-sep-2021, kci received service of a legal petition alleging the following: on (b)(6) 2020, the patient was admitted to the hospital for treatment of a third-degree full thickness burn injury that covered 10% of total body surface area involving the patient's right arm and back.Prior to discharge, the hospital initiated a "mobile" negative pressure wound therapy system [npwt].On (b)(6) 2020, post hospital discharge, the patient was en route home, and experienced "extreme" pain and discomfort that the patient did not experience prior to the "mobile" npwt placement or during the initial initiation and operation of the device.The patient contacted the hospital and was informed not to turn the npwt off and return to the hospital as soon as possible.The patient subsequently presented to the hospital and was admitted to the emergency room."eventually," the hospital personnel turned off and removed the device.The hospital personnel subsequently observed "severe injuries" noted as a result of issues with the "mobile" device.The patient was hospitalized for a period of more than 60 days during which the patient underwent "at least" three surgeries allegedly resulting from the additional injuries sustained due to the "mobile" device.The patient has not completely recovered, and it is anticipated that the patient may need additional surgical intervention.To date, kci has located no record of a kci-manufactured mobile negative pressure device being provided to the plaintiff-patient.Consequently, kci cannot presently confirm the plaintiffs' allegation that a kci-manufactured mobile negative pressure device was provided to the plaintiff-patient, nor can a device evaluation be performed.

Manufacturer Narrative

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged injuries and subsequent surgeries are related to the activ.A.C.¿ therapy system.A device evaluation could not be performed.

Event Description

On 03-dec-2021, a photo was received from the patient's attorney identifying the unit allegedly used at the time of the event as activ.A.C.¿ therapy system serial number (b)(6).The device was not returned to kci; therefore, a device evaluation could not be performed.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM
• 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: 12711131
• MDR Text Key: 280119840
• Report Number: 3009897021-2021-00254
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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: WNDACT
• Device Catalogue Number: 340020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2008
• 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
• Treatment: GABAPENTIN 600MG THREE TIMES A DAY; IMITREX(DOSAGE & FREQUENCY NOT PROVIDED); VENLAFAXINE (DOSAGE & FREQUENCY NOT PROVIDED)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White