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

Model Number VACDSP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided to kci by the patient's family member: the patient allegedly experienced bleeding during a v.A.C.® dressing change, and the patient was hospitalized.The physician discontinued v.A.C.® therapy.No additional information was provided.Per kci record review: v.A.C.® therapy was discontinued on (b)(6) 2022.The v.A.C.® 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.® dressing lot number was not provided, and the dressing was not returned; therefore, a device history record review and a device evaluation could not be performed based on information provided, it cannot be determined that the alleged bleeding event is related to the v.A.C.® dressing.The patient was on blood thinners and has a significant vascular history that may be contributing factors in this event.Multiple unsuccessful attempts were made for additional information.Device labeling, available in print and online, states: contraindications: do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.Warnings: bleeding: with or without using v.A.C.® therapy, certain patients are at high risk of bleeding complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal.Patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to: suturing of the blood vessel (native anastomosis or grafts) / organ, infection, trauma, radiation, patients without adequate wound hemostasis, patients who have been administered anticoagulants or platelet aggregation inhibitors, patients who do not have adequate tissue coverage over vascular structures.If v.A.C.® therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.If active bleeding develops suddenly or in large amounts during v.A.C.® therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop v.A.C.® therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.® therapy units and dressings should not be used to prevent, minimize or stop vascular bleeding.Protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Always ensure that v.A.C.® foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.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.

• 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: 14987239
• MDR Text Key: 295697625
• Report Number: 3009897021-2022-00125
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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
• Date Manufacturer Received: 06/13/2022
• 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: AMLODIPINE 5MG 1 TABLET ORALLY ONCE A DAY; APIXABAN 5MG ONE TABLET ORALLY TWICE A DAY; ASPIRIN 81MG ONE TABLET ORALLY ONCE A DAY; CARVEDILOL 3.125 MG ONE TABLE ORALLY TWICE A DAY; FAMOTIDINE 20MG ONE TABLET ORALLY TWICE A DAY; LINZESS 145 MCG 1 CAPSULE ORALLY ONCE A DAY; ROSUVASTATIN 40MG ONE TABLET ORALLY ONCE A DAY; VANCOMYCIN 1G IV EVERY 12 HOURS
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR
• Patient Sex: Male