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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bacterial Infection (1735)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

The v.A.C.® dressing was not returned; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged infection requiring medication is related to the v.A.C.® dressing.The physician's office nurse indicated the v.A.C.® dressing was left in the patient's wound longer than the manufacturer's recommendations; therefore, this event is being reported due to potential use error.Device labeling, available in print and online, states: warning: keep v.A.C.® therapy on: 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 at the direction of the 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.Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.Wound infection: call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever.Your wound is sore, red or swollen.Your skin itches or you have a rash or redness around the wound.The area around the wound feels very warm -you have pus or a bad smell coming from the wound.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.

Event Description

On (b)(6) 2022, the following information was reported to kci by the patient: patient stated v.A.C.® therapy is on a 2 week hold per the wound care center.He allegedly had an unplanned debridement of his wound at the first wound care appointment.The home health agency had a shortage of nurses, so he was assigned to a wound care center for 1 visit per week.Home health agency is supposed to go twice a week, but they are not.He is completing his own wet to dry dressing changes twice a week.On 21-sep-2022, the following information was reported to kci by the wound care center nurse: the patient allegedly had bone exposure and necrosis to wound area was to the v.A.C.® dressing being left in place for a week.The home health agency did not provide care for a week to lack of staffing.A wound culture for infection is pending with oral and topical antibiotics in process.She stated the reported debridement was due to the necrosis and a bone biopsy was also taken due to the exposure.The patient was first seen in their office on (b)(6) 2022; therefore, she is not sure of the wound appearance prior to her initial visit at their office.On 26-sep-2022, the following information was reported to kci by the physician's office nurse: the debridement was planned and performed due to pre-existing bone exposure and necrosis, not related to v.A.C.® therapy.When seen on (b)(6) 2022, there was some maceration and v.A.C.® therapy was placed on hold until the next scheduled visit on (b)(6) 2022 when v.A.C.® therapy was planned to be resumed.Patient is on antibiotics for infection caused by the v.A.C.® dressing being left in wound for 2 weeks due to no wound care performed by home health agency and patient did not report and refused to be seen by vascular surgeon until (b)(6) 2022.The v.A.C.® dressing lot number was not provided and was not returned; therefore, a device history record review and a device evaluation could not be performed.

• Brand Name: V.A.C.® DRESSING
• Type of Device: 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: 15615110
• MDR Text Key: 301832319
• Report Number: 3009897021-2022-00159
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALUMINUM HYDROXIDE-MAGNESIUM HYDROXIDE 200 MG; CIPRO 500 MG BY MOUTH EVERY 12 HOURS; CLINDAMYCIN 300 MG ORAL CAPSULE 1 CAP EVERY 8; FENTANYL INJECTION 50 MCG IV PUSH EVERY 6 HOURS; INSULIN 40 UNITS SUBCUTANEOUS; LISINOPRIL 5 MG BY MOUTH; NORCO 7.5 MG-325MG 1 TAB EVERY 4 HOURS AS NEEDED; NOVOLOG FLEX PEN 100 UNITS; ONDANSETRON 4 MG 1 TAB BY MOUTH EVERY 6 HOURS; ONDANSETRON INJECTION 4 MG IV PUSH EVERY 6 HOURS; VANCOMYCIN IV PIGGY BACK 1500 MG IV PUSH; ZOSYN IV PIGGY BACK
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG