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 Foreign Body Reaction (1868); Device Embedded In Tissue or Plaque (3165); Drug Resistant Bacterial Infection (4553)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of onset is unknown.The patient was admitted to the hospital with signs and symptoms of infection related to the alleged event on (b)(6) 2021.Thus, (b)(6) 2021 was utilized.V.A.C.® granufoam¿ dressing lot number was not available and the dressing was discarded; therefore, a device history record review and a 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.Kci is also unable to determine if the alleged infection is related to the v.A.C.® granufoam¿ dressing as the patient had a history of recurrent methicillin-resistant staphylococcus aureus infection.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 for over the manufacturer's recommendations.This event is being reported as a 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.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.

Event Description

On 09-jul-2021, the following information was reported to kci by the nurse: the patient was admitted to the hospital due to an embedded foreign material within the wound alleged to be v.A.C.® granufoam¿ dressing.The patient reported the home health never showed up to change the dressing and thus, the patient began performing their own wound care.On 09-jul-2021, clinical records from the physician were received by kci which noted the following: on (b)(6) 2021, the patient was admitted to the hospital for a wound abscess secondary to a retained foreign material as evidenced by increased malodorous drainage and pain at the wound site.The patient had been discharged home from a skilled nursing facility three weeks prior with v.A.C.® therapy in place.Due to a two week wait for home health, the patient began doing their own dressing changes.Upon presenting to the emergency department, the patient reported that they may have left a sponge in the wound and were unsure how long it had been there.The patient complained of increased pain and drainage for one week with nausea and intermittent fevers.The attending physician noted "black sponge" visible within the wound bed, erythema, and induration.On (b)(6) 2021, the patient underwent surgical debridement of "wound vac sponge deeply embedded into the soft tissue." intraoperative wound cultures were taken, which grew methicillin-resistant staphylococcus aureus and proteus mirabilis.The patient was placed on intravenous antibiotics and discharged to a long-term acute care facility.No additional information provided.The v.A.C.® granufoam¿ dressing lot number was not provided and the product was discarded; therefore, a device history record review and device evaluation could not be performed.

• 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: 12277566
• MDR Text Key: 265076284
• Report Number: 3009897021-2021-00202
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 07/09/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 109