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| Model Number WNDFRE |
| Device Problems
Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022); Insufficient Information (3190)
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| Patient Problems
Abrasion (1689); Burn(s) (1757); Erythema (1840); Injury (2348); Skin Burning Sensation (4540)
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| Event Date 12/31/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: the specific date of event was not provided.The alleged event occurred on or about (b)(6) 2019 to (b)(6) 2019 per information provided by the patient's legal representative.Other (code unspecified): the patient reported the device was left at the treating facility, date unknown.Kci has made multiple attempts to locate device at the treating facility, but whereabouts remain unknown per the treating facility's personnel.The treating facility has advised kci that the patient took device home.Based on the information provided, kci could not determine that the alleged event was related to v.A.C.Freedom¿ therapy system.The patient has a significant spinal surgical history with complications, including but not limited to decreased range of motion and scarring to periwound.All medical records made available to kci predate reported event.Device labeling, available in print and online, states: consideration for transitioning the v.A.C.® therapy into homecare: labeling: the prescribing physician and healthcare clinician should be familiar with the v.A.C.® therapy labeling materials that accompany the therapy unit and dressing cartons into the home an information folder is provided with the therapy unit.The prescribing physician and/or healthcare clinician should carefully review these materials with the patient kci offers in-service and training programs for use of the v.A.C.® therapy.Contact your kci representative.In the u.S., call 1-800-275-4524 for scheduling.Precautions protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile / friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.If any signs of irritation or sensitivity to the drape, foam or tubing assembly appear, discontinue use and consult a physician.To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing during drape application.Extra caution should be used with patients with neuropathic etiologies or circulatory compromise.Acrylic adhesive: the v.A.C.® drape has an acrylic adhesive coating, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives.If a patient has a known allergy or hypersensitivity to such adhesives, do not use the v.A.C.® therapy system.If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus, discontinue use and consult a physician immediately.If bronchospasm or more serious signs of allergic reaction appear, seek immediate medical assistance.
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Event Description
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Per review of kci records: on 19-dec-2019, it was reported that the patient presented to the emergency room on (b)(6) 2019, with lower back pain, right lower extremity numbness, and proximal right lower extremity weakness secondary to a ground level fall.Following the patient's inpatient stay, the patient was admitted to an inpatient rehabilitation facility from (b)(6) 2019 until discharge on (b)(6) 2019, when the patient was transitioned home with the v.A.C.Freedom¿ therapy system in place to a dehisced surgical wound located to the patient's posterior neck.On 28-jan-2020, it was reported to kci that the v.A.C.Freedom¿ therapy system was discontinued on (b)(6) 2020 due to surgical closure of the wound.On 03-mar-2020, the following information was reported to kci by the patient's legal representative: the patient reportedly sustained injuries as a result of the alleged misuse of the v.A.C.Freedom¿ therapy system at the patient's treating facility on or about (b)(6) 2019.The patient returned to the treating facility "for a dressing change and again due to a burn to the back as a result of the alleged misuse" of the v.A.C.Freedom¿ therapy system by the treating facility.As of 27-apr-2020, it was reported to kci that a complaint for damages had been filed in superior court of the state of (b)(6).In that complaint prepared by attorneys for the plaintiff, the following was reported: on or about (b)(6) 2019, the patient was discharged home with the v.A.C.Freedom¿ therapy system.On (b)(6) 2019, the patient returned to the treating facility for a dressing change.During the dressing change the v.A.C.Freedom¿ therapy system was "detached, manipulated, modified, moved and re-attached from/to the [patient's] body.When the [v.A.C.Freedom¿ therapy system] was re-attached [by treating facility] it was.Attached in a manner [allegedly] different from.The method, procedure, and manner in which it was intended and recommended by the manufacturer." on or about (b)(6) 2019, the patient noticed unusual heat on the patient's back and thought something was "burning".The patient returned to the treating facility where the v.A.C.Freedom¿ therapy system was removed.Upon removal "it was discovered that the [v.A.C.Freedom¿ therapy system] had caused a severe and permanent burn." the patient alleged that the treating facility's handling of the v.A.C.Freedom¿ therapy system "resulted in, and caused, component parts of the [v.A.C.Freedom¿ therapy system] to become unreasonably hot." the v.A.C.Freedom¿ therapy unit was not returned to kci; therefore, a device evaluation could not be performed.
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Event Description
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On (b)(6)2020, the following information was reported to kci by the patient's legal representative: the patient reportedly sustained injuries as a result of the alleged misuse of the v.A.C.Freedom¿ therapy system at the patient's treating facility on or about (b)(6)2019.The patient returned to the treating facility "for a dressing change and again due to a burn to the back as a result of the alleged misuse" of the v.A.C.Freedom¿ therapy system by the treating facility.
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Manufacturer Narrative
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Mdr-3009897021-2020-00212 submitted on (b)(6)2020 reported the following: section b5: on (b)(6)2020, the following information was reported to kci by the patient's legal representative.Section g4: (b)(6)2020.Corrections: section b5: on (b)(6)2020, the following information was reported to kci by the patient's legal representative.Section g4: (b)(6)2020.Based on the corrected information, kci's assessment remains the same; kci could not determine that the alleged event was related to v.A.C.Freedom¿ therapy system.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.
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Event Description
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On 05-nov-2020, kci received photos of the event, dates unknown.Medical assessment of the first photo reveals a linear track of denuded and excoriated skin extending from the mid upper back to the left lateral side.There is a non-kci product in place covering the nape and extending straight down to the middle of the back.The second photo reveals progressive improvement of the excoriated/denuded left lateral linear track with no dressing in place.
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Manufacturer Narrative
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Based on the photos provided, kci determined that the patient did not experience a "severe and permanent burn" to the back as originally alleged as the photos reveal excoriated and denuded skin on the patient's mid upper back to the left lateral side.Kci could not determine that the alleged burning sensation, or excoriation and denuded skin were related to the v.A.C.Freedom¿ therapy system.Kci is in the process of reviewing the clinical records received for the patient.Kci has determined the probable origin of the alleged burning sensation was associated with the excoriation and denuded skin probably caused by improper placement the v.A.C.Freedom¿ therapy system.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.
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Event Description
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On (b)(6) 2020, kci was provided clinical records that noted the following: on (b)(6) 2019, the patient presented for a post-operative follow-up appointment at a clinic located within the treating facility.On (b)(6) 2019, the patient's family member reported a technical issue with the v.A.C.Freedom¿ therapy system to the rehabilitation facility.Clinical records indicate the patient was advised to contact the wound vac supplier or go to the emergency department.On (b)(6) 2019, the patient presented to the emergency department for a wound evaluation.The patient's family member reported that the v.A.C.® dressing was last changed a week ago.The nurse noted redness and tenderness to upper back.The physician observed the patient and noted that the patient described the pain as "uncomfortable".On (b)(6) 2020, the v.A.C.® dressing was removed in the emergency room and the physician noted "skin with significant dermatitis and irritation under the sponge".A non-kci product was placed over the incision site and wound care was consulted.The physician's assessment noted "wound vac induced dermatitis/irritation from prolonged placement".The wound care nurse recommended the application of an over-the-counter ointment/emollient to the areas of denuded and flaky skin along the left posterior back every 12 hours, to be covered with an abdominal pad and secured with tape.The wound care nurse documented the color of excoriation as pink, red, and yellow, and the pattern as flat, linear, and ring-shaped.On (b)(6) 2020, the patient was discharged home with family in stable condition and denied any complaint of pain.On (b)(6) 2020, kci received additional photos of the event, dates unknown.Medical assessment of the photos revealed the excoriated and denuded skin completely healed with no permanent injury or scarring evident.
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Manufacturer Narrative
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Based on the clinical records and additional photos provided, it was determined that the patient experienced excoriation and denuded skin and did not experience a "severe and permanent burn" to the back as originally alleged.The clinical records and additional photos reveal the excoriated and denuded skin completely healed with no permanent injury or scarring evident.The clinical records noted the v.A.C.® dressing was left in place for one week and "wound vac induced dermatitis/irritation from prolonged placement", and the clinic records and photos do not indicate that the periwound skin was protected to prevent foam from overlapping onto intact skin, which could have contributed to the alleged burning sensation.Kci has deemed this event as not reportable based on the additional information received on 11-nov-2020 and 07-dec-2020.Device labeling, available in print and online, states: precautions protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile / friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.- if any signs of irritation or sensitivity to the drape, foam or tubing assembly appear, discontinue use and consult a physician.- to avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing during drape application.- extra caution should be used with patients with neuropathic etiologies or circulatory compromise.Dressing changes wound being treated with the v.A.C.®therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48 to 72 hours but no less than three times per week, with frequency adjusted by the clinician as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48 - 72 hours; the dressing change intervals should be based on a continuing evaluation of wound condition and the patient's clinical presentation, rather than a fixed schedule.Incision site dressing application 1.Select appropriate dressing.2.Clean skin around incision, per institution protocol or physician's orders.3.Apply skin protectant / skin adhesive to area around the incision and approximately 5.1 cm on either side to assist with dressing seal integrity.4.Protect intact skin on both sides of the suture line with vac drape, hydrocolloid, or other transparent film ('picture frame' the suture or staple line), leaving the suture line exposed.5.Place a non-adherent layer (i.E.Oil emulsion, petroleum or silicone dressing), minimum 7.6 cm wide, over length of incision.Include at least 2.5 cm over each end of the incision.6.Cut v.A.C.® granufoam¿ dressing into strips minimally 6.3 cm wide.Cut enough strips to cover entire incision and at least 2.5 cm over either end.7.Place vac granufoam dressing strips onto entire length of non adherent layer.If multiple strips are used, ensure that the strips touch each other so that negative pressure is applied over the length of the incision.Do not allow vac granufoam dressing to touch intact skin.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.
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