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 Codes	Abscess (1690); Bacterial Infection (1735); Pain (1994)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 03-mar-2022, the following information was provided to kci by the patient: on (b)(6) 2022, the home health nurse observed the patient who was allegedly experiencing increased pain and the nurse expressed concern for a possible infection.On (b)(6) 2022, the physician observed the patient and removed the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The physician reportedly informed the patient that the wound needed air.On (b)(6) 2022, the nurse re-applied the activ.A.C.¿ ion progress¿ remote therapy monitoring system and the patient was placed on antibiotic therapy.On 28-mar-2022, the following information was provided to kci by the physician: on (b)(6) 2022, the patient underwent surgical excision of the fistula tract due to a periumbilical cyst, and the activ.A.C.¿ ion progress¿ remote therapy monitoring system was applied with dressing changes reportedly performed three times a week.On (b)(6) 2022, the physician observed the patient during the one week postoperative follow up and noted the patient's wound allegedly appeared infected.The physician allegedly suspected the "sponge" was not being properly placed deep enough, as it reportedly appeared superficial with an abscess deeper in the wound.The activ.A.C.¿ ion progress¿ remote therapy monitoring system was discontinued, and an alternate dressing regimen was applied.On 28-mar-2022, a device history record review of v.A.C.® granufoam¿ dressing lot number 9387898v009 was performed.All end release testing of product and packaging met specifications.
Additional Manufacturer Narrative
The v.A.C.® granufoam¿ dressing was not returned to kci.Based on the information provided, it cannot be determined that the alleged pain and infection are related to the v.A.C.® granufoam¿ dressing.The patient was recently hospitalized for an infection requiring surgical intervention and antibiotic therapy three days prior to this event.The physician noted the alleged event may be due to use error as the v.A.C.® granufoam¿ dressing was superficially placed in the patient's wound.Therefore, this event is being reported due to potential use error.A device history record review determined all end release testing of product and packaging met specifications.Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.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 ,and cellulitis of the incision area.Maintaining a seal: maintaining a seal around the dressing is key to successful v.A.C.® therapy.Recommendations to maintain the integrity of the seal: ensure v.A.C.® granufoam¿ dressing is appropriate for the depth of the wound by either cutting or beveling it, or use a specific thinner v.A.C.® granufoam¿ dressings where indicated.

• 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: 13976415
• Report Number: 3009897021-2022-00068
• Device Sequence Number: 6229276
• Product Code: OMP
• UDI-Device Identifier: 00849554000704
• UDI-Public: 010084955400070417240731109387898V009
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: 07/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 9387898V009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: AUGMENTIN (DOSAGE NOT PROVIDED) BID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 139 KG