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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Date 07/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided to kci from the customer: the patient presented to the hospital for assistance with a technical issue but was unable to resolve the issue.The patient was already at 24 hours without active therapy and the decision was made to remove the v.A.C.® dressing.The patient was initially scheduled for a dressing change on tuesday, july 19th.However, the dressing was removed a day early on july 18th as the wound had allegedly regressed and exhibited a foul odor.On (b)(6) 2022, the following information was provided by the kci representative: on (b)(6) 2022: the patient experienced a technical issue with the unit and contacted kci.A new unit was requested.On (b)(6) 2022: the new unit arrived at the patient´s home.Due to a technical issue, the new unit was not placed, and the patient went "more than 12 hours without therapy." the patient was instructed to go to the hospital for assistance in placing the new unit but was unsuccessful."with more than 24 hours without the therapy (non-functioning dressing), the clinical specialist contacted the assistant doctor, explaining the risks of maintaining a therapy that had not worked for a long time, it was decided to remove the dressing.There was a worsening of the wound, the wound was with a foul odor and the dressing was removed.A conventional dressing was applied.There was no worsening in the patient's health status, only in the wound." on (b)(6) 2022: the patient was admitted for placement of the v.A.C.® dressing.On (b)(6) 2022, the following information was reported by the customer: on 19-jul-2022, the patient allegedly underwent debridement due to increased slough noted in the wound.The healthcare provider believes the slough formation was due to the v.A.C.® dressing being left in place for over 24 hours without active therapy and wetness in the wound.The v.A.C.® dressing lot number was not provided and the product was not returned; therefore, a device history record review and device evaluation could not be performed.

Manufacturer Narrative

The v.A.C.® dressing lot number was not provided, and the dressing was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on the information provided, it cannot be determined that the patient's wound allegedly getting worse and developing slough is related to the v.A.C.® dressing.The patient did have a pre-existing infection prior to initiation of v.A.C.® therapy.The healthcare provider believed the v.A.C.® dressing being left in place for over 24 hours without active therapy led to wetness in the wound and slough formation.Therefore, this event is being reported due to potential use error.Device labeling, available in print and online, states: warning: never leave a v.A.C.® dressing in place without active v.A.C.® therapy for more than two hours.If therapy is off for more than two hours, remove the old dressing and irrigate the wound.Either apply a new v.A.C.® dressing from an unopened sterile package and restart v.A.C.® therapy; or apply an alternate dressing, such as a wet to moist gauze, as approved during times of extreme need, by treating physician.Deterioration of the wound 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.Wound infection call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever, your wound is sore, red or swollen, your skin itches or you have a rash or redness around the wound, the area around the wound feels very warm, you have pus or a bad smell coming from the wound, infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as wound conditions, treatment goals.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

• Brand Name: V.A.C.® DRESSING
• 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: 15217552
• MDR Text Key: 297787408
• Report Number: 3009897021-2022-00131
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female