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 Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2022

Event Type  Injury  

Event Description

On 18-jun-2022, the following information was provided to kci by the family member: on (b)(6) 2022, the patient missed her wound care appointment so the patient's family member attempted to remove the foreign material alleged to be v.A.C.® granufoam¿ dressing from the wound.The foreign material was allegedly stuck to the wound so the family member shut off the activ.A.C.¿ ion progress¿ remote therapy monitoring system for hours and allowed the wound to soak.The family member also poured dish soap inside the wound as well as poked holes in the dressing and poured saline inside.The patient experienced severe pain with any attempt at removal of the foreign material.The patient receives v.A.C.® granufoam¿ dressing changes twice per week at the wound care center, last changed on (b)(6) 2022.On 23-jul-2022, the following information was provided to kci by the wound care center: the patient missed her appointments on (b)(6) 2022.There are no hospital or emergency room records for the patient in the (b)(6) health system database regarding the alleged event.On 23-jul-2022, the following information was provided to kci by the vascular surgery office: the patient cancelled her appointment scheduled for on (b)(6) 2022 due to allegedly being inpatient.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 completed.Based on the information provided, kci cannot determine if and what medical or surgical intervention was required to remove the foreign material alleged to be v.A.C.® granufoam¿ dressing.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.The healthcare professionals involved with the patient's care are unaware of the event and are unable to locate any medical records to confirm the alleged event.The family member reported the patient receives dressing changes twice per week at the wound care center, which is outside of the manufacturer's recommendations.Additionally, the patient missed their scheduled wound care appointment, and the family member attempted removal of the v.A.C.® granufoam¿ dressing by employing methods not according to the manufacturer's recommendations.Furthermore, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was shut off and the alleged v.A.C.® granufoam¿ dressing was left in place for 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: warning: keep v.A.C.® therapy on: 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 at the direction of the 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.

• 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: 15014301
• MDR Text Key: 295877634
• Report Number: 3009897021-2022-00116
• 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: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2022

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: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2022
• Initial Date FDA Received: 07/14/2022
• 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): Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Female