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

Model Number VACDSP

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Device identifier was not provided and the device was not returned for evaluation.Based on information provided, it cannot be determined when the foreign body alleged to be v.A.C.® dressing was placed in the wound.The foreign material was discarded and was not returned to kci for identification; therefore, kci is unable to confirm its identity.This report is being filed due to possible user error.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 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 26-feb-2021, the following information was provided to kci by the patient: the v.A.C.® dressing was in place for two weeks and could not be removed by the physician on (b)(6) 2021.On (b)(6) 2021, the patient went to the operating room to have the v.A.C.® dressing removed.The patient was on antibiotics for prophylaxis but there was no active infection.On 24-mar-2021 the following information was reported to kci by the nurse: the v.A.C.® dressing was removed surgically, and the patient was fine.The v.A.C.® dressing lot number was not available and the product was not returned; therefore, a device history record review and a device evaluation could not be performed.

• 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: 11579573
• MDR Text Key: 260314669
• Report Number: 3009897021-2021-00059
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• 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
• Date Manufacturer Received: 02/26/2021
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR