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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the following information received via clinical records from the physician were reviewed: the patient underwent incision, drainage and removal of retained foreign material alleged to be v.A.C.Whitefoam¿ dressing on (b)(6) 2023.Patient had purulent drainage from left groin.Ct scan revealed retained dressing within the wound.Patient underwent incision and drainage on (b)(6) 2023 where a piece of "old white foam from his dressings" was removed.The v.A.C.Whitefoam¿ 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.

Manufacturer Narrative

Based on the information provided, kci cannot determine when the foreign material alleged to be v.A.C.Whitefoam¿ dressing was placed in the wound.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.It was indicated the v.A.C.Whitefoam¿ 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 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.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.

• Brand Name: V.A.C. WHITEFOAM¿ 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: 16436835
• MDR Text Key: 310169198
• Report Number: 3009897021-2023-00016
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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: 01/30/2023
• 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: ACETAMINOPHEN 500MG CAP 1 PO PRN.; AMIODARONE 200MG TAB 1 PO.; AMLODIPINE 10MG TAB 1 PO DAILY.; AMOXICILLIN 875MG POTASSIUM CLAVULANATE 125MG TAB.; ASPIRIN 81MG 1 PO AM.; ATORVASTATIN 40MG TAB PO DINNER.; BISACODYL 5MG TAB 1 PO PRN.; CLOPIDOGREL 75MG TAB PO DAILY.; ERGOCALCIFEROL 1250MCG CAP 50 MCG PO DAILY.; EZETIMIBE 10MG TAB 1 PO DAILY.; FERROUS SULFATE 325MG TAB 1 PO TID.; FUROSEMIDE 20MG TAB 1 PO DAILY.; GLIMEPIRIDE 1MG TAB PO BID.; HYDRALAZINE 100MG TAB 1 PO TID.; ISOSORBIDE MONONITRATE 60 MG TAB 1 PO AM.; LABETALOL 100MG TAB 50 MG PO DAILY.; LEVOTHYROXINE 50 MCG TAB 1 PO AM.; NITROGLYCERIN 0.4MG SUBLINGUAL TAB AS DIRECTED.; VIT B COMPLEX 1 TAB PO DAILY.; ZINC GLUCONATE 50MG TAB 1 PO LUNCH.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 146 KG