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

Model Number	VACDSP
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the following information was provided to kci by the patient: on 01-nov-2023, the surgeon removed four inches of adhered foam, alleged to be v.A.C.® granufoam¿ dressing, from a tunneled area.The foam was tucked deep inside of the tunneled area and had granulation tissue grown around it, requiring the surgeon to have to cut the foam out.The surgeon believed that the alleged v.A.C.® granufoam¿ dressing has been in the tunneled area since the patient's last hospital stay.On (b)(6) 2023, the following information was provided to kci by the medical assistant: the v.A.C.® granufoam¿ dressing was deeply tucked and embedded inside the tunnel and had to be surgically excised.The surgeon stated that the foam had been in the tunnel for an undetermined amount of time, but was likely in the tunnel for a significant amount of time due to the amount of surgical excision required.The v.A.C.® granufoam¿ dressing lot number was not provided, and the product was not returned; therefore, a device evaluation and a device history record review could not be performed.
Additional Manufacturer Narrative
Based on the information provided, it could not be determined when the foreign material alleged to be v.A.C.® granufoam¿ dressing was placed in the wound.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.A device evaluation and a device history record review could not be performed.The physician noted that the v.A.C.® granufoam¿ dressing was presumably left in the wound over 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.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.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.® 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: 18234452
• Report Number: 3009897021-2023-00073
• Device Sequence Number: 11314527
• Product Code: OMP
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/29/2023

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 Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ALBUTEROL 90 MCG/PUFF INHALER, 2 PUFFS EVERY 6 HOU; BIOTIN ONE TABLET DAILY; CELLCEPT 500 MG, ONE TABLET TWO TIMES PER DAY; CITRACAL + D, 315 MG-200 UNITS, TWICE PER DAY; CYMBALTA 30 MG DR, DAILY; CYMBALTA 60 MG DR, DAILY; FOLIC ACID, 1 MG TABLET, DAILY; LAMICTAL 200 MG TABLET, TWICE PER DAY; LYRICA 200 MG, TWO CAPSULES EVERY NIGHT; MICRO-K, 10 MEQ CR, ONE DAILY; MIRALAX 17G PACKET, ONE PACKET TWO TIMES PER DAY; MULTIVITAMINS/MINERALS, ONE DAILY; NOLVADEX 20 MG TABLET, ONE TABLET DAILY; PLAQUENIL 200 MG TABLET, TWO TABLETS NIGHTLY; PREDNISONE 5 MG TABLET, TWO TABLETS EVERY MORNING; PROBIOTIC-10, TAKE ORALLY TWO TIMES PER DAY; PROTONIX 40 MG, ONE TABLET EVERY EVENING; SYNTHROID 75 MCG TABLET, ONE TABLET EVERY MORNING; TOPAMAX 100 MG TABLET, ONE TABLET TWO TIMES DAILY; TYLENOL 500 MG TABLET, TWO TABLETS TWICE PER DAY; VITAMIN B-12, 100 MCG TABLET, 0.5 TABLET DAILY; VITAMIN D-3, 250 MCG (10,000 UNITS) DAILY; ZYRTEC 10 MG DAILY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 155 KG