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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Pain (1994); Foreign Body In Patient (2687)

Event Date 05/02/2022

Event Type  Injury  

Event Description

On 09-nov-2022, the following information from the physician was obtained via kci record review: on (b)(6) 2022, "she does have a small area of fluctuance at the superior medial aspect of the open wound.In order to adequately drain the small area, a small nick was made with a scalpel.There was a very slight amount of purulence seen.She is still tender over the entire mastectomy site.There was not enough fluid to culture, however i will put her on a short course of oral antibiotics." on (b)(6) 2022, during procedure for right mastectomy wound incision and drainage: "incision was extended revealing black sponge from previous wound vac changes.This was densely adherent to the surrounding skin and subcutaneous tissue, and was very painful to try to attempt removal at bedside due to pain.Will take her to the operating room in the morning for removal of foreign body of the right chest mastectomy incision." on (b)(6) 2022, "the vac sponge was densely incorporated into the surrounding subcutaneous tissue, skin, and pectoralis muscle.It was removed and handed off as a specimen.There were small flecks of sponge that were picked and removed with debakeys.Patient tolerated the procedure well without apparent complications." on (b)(6) 2022, "she has been undergoing vac treatments of the new wound, with significant improvements.It is very shallow and decreased in size.She still has an area inferior lateral to this that continues to have green drainage.We had put her on some antibiotics for presumed pseudomonas at the time of removal of the retained sponge while she was last in the hospital." no additional information was provided.The v.A.C.® granufoam¿ 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.® granufoam¿ 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.Based on information provided, kci cannot determine when the foreign material alleged to be v.A.C.® granufoam¿ dressing was placed in the wound and if the alleged infection is related to the v.A.C.® granufoam¿ dressing.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.The foreign material was allegedly left in the wound longer than the manufacturer's recommendations.Therefore, this event is being reported due to potential use error.Device labeling, available in print and online, states: warnings- 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.Dressing changes wounds 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 48-72 hours, but no less than 3 times a 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 changing intervals should be based on a continuing evaluation of the wound condition and the patient's clinical presentation, rather than a fixed schedule.Foam placement: always use v.A.C.® dressings from sterile packages that have not been opened or damaged.Do not place any foam dressing into blind/unexplored tunnels.The v.A.C.® whitefoam¿ dressing may be more appropriate for use with explored tunnels.Do not force foam dressings into any area of the wound, as this may damage tissue, alter the delivery of negative pressure or hinder exudate and foam removal.Always count the total number of pieces of foam used in the wound.Document the foam quantity and dressing change date on the drape or foam quantity label if available, and in the patient's chart.Foam removal: v.A.C.® foam dressings are not bioabsorbable.Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces are removed as were placed.Foam left in the wound for greater that the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing the foam from the wound or lead to infection or other adverse events.If dressing adheres to wound consider introducing sterile water or normal saline into the dressing, waiting 15 - 30 minutes, then gently removing the dressing from the wound.Regardless of treatment modality, disruption of the new granulation tissue during any dressing change may result in bleeding at the wound site.Minor bleeding may be observed and considered expected.However, patients with increased risk of bleeding, as described on page 8, have a potential for more serious bleeding from the wound site.As a precautionary step, consider using v.A.C.Whitefoam¿ dressings or nonadherent material underneath the v.A.C.® granufoam¿ dressings to help minimize the potential for bleeding at dressing removal in these patients.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.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.Precautions: the v.A.C.® therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area.Untreated or inadequately treated infection.Inadequate hemostasis of the incision.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.® GRANUFOAM¿ 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: 15890778
• MDR Text Key: 304588146
• Report Number: 3009897021-2022-00172
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• 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
• Treatment: CLINDAMYCIN 150 MG X 5 DAYS.; KLONOPIN 0.5 MG.; LEXAPRO 10 MG DAILY.; SERAQUEL FOR SLEEP.; TYLENOL 325 MG.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 103 KG