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	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2022
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, kci cannot determine when the foreign material alleged to be v.A.C.® granufoam¿ dressing was placed in the wound.It is unknown if surgical intervention was performed.The er record did not indicate the method of removal.All end release testing of the product and packaging met specifications.The v.A.C.® granufoam¿ dressing was not returned; therefore, a device evaluation could not be performed.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.
Event or Problem Description
On 14-feb-2022, the following information was provided to kci by the patient's family member: on 13-feb-2022, the home health nurse was unable to remove foreign material alleged to be v.A.C.® granufoam¿ dressing.The patient went to the emergency room (er), and the surgeon removed the v.A.C.® granufoam¿ dressing.The surgeon then reapplied the activ.A.C.¿ ion progress¿ remote therapy monitoring system.On 18-feb-2022, the following information was provided to kci by the home health clinical manager: the er record indicates that the vascular surgeon successfully removed the v.A.C.® granufoam¿ dressing after the er clinical team allegedly attempted removal and was unsuccessful.The removal method by the surgeon was not indicated.On 04-mar-2022, the following information was provided to kci via clinical records: on (b)(6) 2022, the home health nurse was unable to remove the v.A.C.® granufoam¿, despite extensive soaking, due to the patient's pain during the procedure.The patient was referred to the emergency department (ed) for further management.A wound care nurse evaluated the patient and was also unable to remove the v.A.C.® granufoam¿.The vascular surgeon was called to evaluate the patient and was able to change the v.A.C.® granufoam¿ after administering a local anesthetic.The patient was discharged from the ed with plans for continuing wound care by the home health nurses.The patient was provided with a prescription for doxycycline prophylactically to prevent infection.A device history record review for v.A.C.® granufoam¿ dressing lot number 9421892v009 was completed.All end release testing of the 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: 13790117
• Report Number: 3009897021-2022-00054
• Device Sequence Number: 4023267
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 0100849554002098172408311094
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/16/2022

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: 08/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 9421892V009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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; HUMALOG 100 UNITS/ML PER SLIDING SCALE; LIPITOR 80 MG NIGHTLY; METFORMIN 1000 MG TWO TIMES DAILY; MULTIPLE VITAMIN DAILY; PLAVIX 75 MG DAILY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic