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

Model Number VACDSP

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

Patient Problem Swelling (2091)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

V.A.C.® granufoam¿ dressing lot number was not provided.Based on information provided, it cannot be determined that the alleged reaction / swelling is related to the v.A.C.® granufoam¿ dressing.Kci has made multiple unsuccessful attempts to obtain additional clinical information.Device labeling, available in print and online, states: acrylic adhesive: the v.A.C.® drape has an acrylic adhesive coating, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives.If a patient has a known allergy or hypersensitivity to such adhesives, do not use the v.A.C.® therapy system.If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus, discontinue use and consult a physician immediately.If bronchospasm or more serious signs of allergic reaction appear, seek immediate medical assistance.Precautions the v.A.C.® therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area.Untreated or inadequately treated infection.Inadequate hemostasis of the incision.Cellulitis of the incision area.

Event Description

On (b)(6) 2020, the following information was reported to the kci by the patient: the patient's leg was allegedly swelling due to a reaction to the v.A.C.® granufoam¿ dressing.No other information available.The v.A.C.® granufoam¿ dressing lot number was not provided; therefore a device history record review could not be performed.

• Brand Name: V.A.C. GRANUFOAM DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; 6203 farinon drive; san antonio, tx
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, tx ; 2556438
• MDR Report Key: 9913542
• MDR Text Key: 188508204
• Report Number: 3009897021-2020-00133
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 110 YR