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	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to kci for evaluation.Based on information provided, it was determined that the foreign body alleged to be v.A.C.® granufoam¿ dressing was placed in the wound on (b)(6) 2020.The dressing change occurred on (b)(6) 2020.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.It was reported that a protective barrier was not used between the foam and the wound bed.Device labeling, available in print and online, states: 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 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 (b)(6) 2020, the following information was reported to kci by the patient: on (b)(6) 2020, a foreign material alleged to be v.A.C.® granufoam¿ dressing was removed from the wound, the wound was inflamed and began to bleed and the patient went to the emergency room to resolve.Per the patient, the nurse stated a protective barrier was not used between the foam and the wound bed and potentially caused the foreign material to adhere.On (b)(6) 2020, the patient underwent a debridement to remove the remaining foreign material from the wound.On (b)(6) 2020, the following information was reported to kci by the nurse: the bleeding experienced by the patient was resolved with pressure, and an alternate dressing was applied.A device history record review for the v.A.C.® granufoam¿ dressing is currently pending completion.
Additional Manufacturer Narrative
Based on the additional information obtained regarding the device, kci's assessment remains the same: the foreign body alleged to be v.A.C.® granufoam¿ dressing was placed in the wound on (b)(6) 2020.The dressing change occurred on (b)(6) 2020.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.All end release testing of product and packaging met specifications.
Event or Problem Description
On (b)(6) 2020, a device history record review for the v.A.C.® granufoam¿ dressing lot number 8278893v009 was completed.All end release testing of product and packaging met specifications.

• Brand Name: V.A.C. GRANUFOAM DRESSING
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• MDR Report Key: 10766848
• Report Number: 3009897021-2020-00973
• Device Sequence Number: 1125968
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 010084955400209817230630108278893V009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 06/30/2023
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 8278893V009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 28 YR