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 Codes	Necrosis (1971); Skin Inflammation/ Irritation (4545)
Date of Event	04/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the following information was provided to kci by the patient's family member: the home health agency nurse has not shown up since the veteran affairs nurse applied v.A.C.® therapy on (b)(6) 2022.The patient's family member is a nurse and performed the dressing change due to technical issues on (b)(6) 2022.The family member noticed v.A.C.® granufoam¿ dressing was placed on intact skin and allegedly a new sore was present with some redness.On (b)(6) 2022, the following information was provided to kci by the nurse case manager: the patient was noted to have allegedly developed necrotic tissue and the activ.A.C.¿ ion progress¿ remote therapy monitoring system was discontinued.On (b)(6) 2022, the following information was provided to kci by the physician: the activ.A.C.¿ ion progress¿ remote therapy monitoring system was working just fine and granulating well.When the patient was seen last week, the v.A.C.® granufoam¿ dressing was put on top of the lip of skin and when v.A.C.® therapy was turned on and compressed continuously, there was a little bit of edge necrosis.The v.A.C.® granufoam¿ dressing wasn't confined in the wound and was oversized.The patient's wound is narrow and it's hard to place v.A.C.® granufoam¿ dressing inside.The patient was seen yesterday, and the wound looks fine.The necrosis was debrided last week, and the wound continues to granulate.On (b)(6) 2022, a device history record review was completed for v.A.C.® granufoam¿ dressing lot number 9511896v011.All end release testing of product and packaging met specifications.The v.A.C.® granufoam¿ dressing lot number was not returned; therefore, a device evaluation could not be performed.
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, it cannot be determined that the alleged new sore, redness, and necrotic tissue are related to the v.A.C.® granufoam¿ dressing.All end release testing of product and packaging met specifications.It was reported that the v.A.C.® granufoam¿ dressing came into contact with intact skin against the manufacturer's recommendations.This event is being reported due to potential use error.Device labeling, available in print and online, states: precautions protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile / friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.Multiple layers of v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration.If any signs of irritation or sensitivity to the drape, foam, or tubing assembly appear, discontinue use and consult a physician.To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing during drape application.Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.Deterioration of the wound if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: -in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.
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, it cannot be determined that the alleged new sore, redness, and necrotic tissue are related to the v.A.C.® granufoam¿ dressing.All end release testing of product and packaging met specifications.It was reported that the v.A.C.® granufoam¿ dressing came into contact with intact skin against the manufacturer's recommendations.This event is being reported due to potential use error.Device labeling, available in print and online, states: precautions protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile / friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.Multiple layers of v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration.If any signs of irritation or sensitivity to the drape, foam, or tubing assembly appear, discontinue use and consult a physician.To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing during drape application.Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.Deterioration of the wound if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: -in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.

• 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: 14489521
• Report Number: 3009897021-2022-00097
• Device Sequence Number: 4808576
• Product Code: OMP
• UDI-Device Identifier: 00849554002463
• UDI-Public: 010084955400246317241031109511896V011
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/24/2022

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: 10/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275053
• Device Lot Number: 9511896V011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male