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

Model Number	VACDSP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The v.A.C.® granufoam¿ dressing was not returned; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged bleeding event requiring surgical intervention is related to the v.A.C.® granufoam¿ dressing.The patient was on two blood thinners and has a significant vascular history including a history of bleeding events prior to v.A.C.® therapy that may be contributing factors in this event.All end release testing of product and packaging met specifications.Device labelling, 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 o 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.
Event or Problem Description
On (b)(6) 2022, the following information was provided to kci by the patient's emergency contact: on (b)(6) 2022, upon removal of the v.A.C.® granufoam¿ dressing, the patient's wound allegedly began to bleed, and the home health nurse was reportedly unable to control the bleeding.The patient subsequently presented to the emergency room and the physician advised there was allegedly a small tear in an artery.The physician used a suture to ligate the artery, re-applied the activ.A.C.¿ ion progress¿ remote therapy monitoring system and the patient was discharged home.On (b)(6) 2022, the following information was provided to kci by the visiting nurse association nurse: the patient was on two blood thinners, aspirin and clopidogrel, and the patient has a history of bleeding events prior to activ.A.C.¿ ion progress¿ remote therapy monitoring system placement.No additional information was provided.On 30-may-2022, a device history record review for the v.A.C.® granufoam¿ dressing lot number 9543892v009 was completed.All end release testing of product and packaging met specifications.The v.A.C.® granufoam¿ dressing was not returned; therefore, a device evaluation could not be performed.

• Brand Name: V.A.C.® GRANUFOAM¿ DRESSING
• Common Device Name: 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: 14567376
• Report Number: 3009897021-2022-00111
• Device Sequence Number: 12206090
• Product Code: OMP
• UDI-Device Identifier: 00849554000704
• UDI-Public: 010084955400070417241031109543892V009
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K133276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 9543892V009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 81 MG DAILY; CLOPIDOGREL 75 MG DAILY; EZETIMIBE 10 MG DAILY; LANTUS SOLOSTAR U-100 UNIT/ML TWICE A DAY; LISINOPRIL 5 NG DAILY; METFORMIN 1,000 MG TWICE A DAY; SIMVASTATIN 80 MG DAILY; VITAMIN D3 125 MCG (5,000 UNIT) DAILY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 85 KG