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

Model Number	VACDSP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device information: activ.A.C.¿ therapy system serial number (b)(4) and unique identifier (udi) (b)(4).Device manufacture date: activ.A.C.¿ therapy system: 15-oct-2019.Based on information provided, it cannot be determined that the alleged graft failure is related to the v.A.C.® simplace¿ dressing.Device labeling, available in print and online, states: continuous therapy is also generally recommended for patients at increased risk of bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute enteric fistulae.Continuous therapy for duration of 7 days with no dressing changes is also generally recommended for use of v.A.C.® therapy with a new graft placement.Apply v.A.C.® dressing immediately after graft placement and begin therapy as soon as possible.When using v.A.C.® granufoam¿ dressings, a non-adherent dressing should be placed directly over the graft / tissue.In general, the pressure setting used to prepare the recipient bed before grafting should be continued after grafting.Continuous therapy should be used to provide a constant bolster.
Event or Problem Description
On (b)(6) 2020, the following information was reported to kci by the patient: on (b)(6) 2020, the patient's skin graft was allegedly removed when the nurse changed the v.A.C.® simplace¿ dressing.On 06-feb-2020, the following information was reported to kci by the nurse: the graft was reapplied on (b)(6) 2020 and v.A.C.® therapy resumed.On 18-feb-2020, a device history record review for v.A.C.® simplace¿ dressing lot number 6829990v007 was completed.All end release testing of the product and packaging met specifications.A device evaluation of activ.A.C.¿ therapy unit is currently pending completion.
Additional Manufacturer Narrative
Mdr-3009897021-2020-00065 submitted on 26-feb-2020 noted the following: b3: date of event: (b)(6) 2020.B4: date of this report: 26-jan-2020.B5: describe event or problem: a device evaluation of activ.A.C.¿ therapy unit is currently pending completion.H3: device evaluated by manufacturer?: no: device evaluation anticipated, but not yet begun.Correction: b3: date of event: (b)(6) 2020.B4: date of this report: 26-feb-2020.B5: describe event or problem: the v.A.C.® simplace¿ dressing was not returned; therefore, a device evaluation could not be performed.H3: device evaluated by manufacturer?: no: other - device not returned.; not returned to manufacturer h10: corrected data: h3: other (code unspecified, describe in h10): the v.A.C.® simplace¿ dressing was not returned; therefore, a device evaluation could not be performed.Based on the corrections, kci's assessment remains the same; it cannot be determined that the alleged graft failure is related to the v.A.C.® simplace¿ dressing.
Event or Problem Description
The v.A.C.® simplace¿ dressing was not returned; therefore, a device evaluation could not be performed.

• Brand Name: V.A.C. SIMPLACE DRESSING
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio,
• MDR Report Key: 9760211
• Report Number: 3009897021-2020-00065
• Device Sequence Number: 14067648
• Product Code: OMP
• UDI-Device Identifier: 00849554001947
• UDI-Public: 010084955400194717220731106829990V007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032310
• 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): 09/03/2021

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: 07/31/2022
• Device Model Number: VACDSP
• Device Lot Number: 6829990V007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 09/03/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104