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

Model Number	VACDSP
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 19-nov-2021, the following information was reported to kci by the patient: on (b)(6) 2021, the patient allegedly developed a bad rash and v.A.C.® therapy was placed on hold.The patient has a follow-up appointment scheduled on (b)(6) 2021, and the physician will reassess the wound.On (b)(6) 2021, the following information was reported to kci by the wound care center office manager: the reported rash was a fungal infection localized under the v.A.C.® drape due to the patient leaving the v.A.C.® drape attached over night without active v.A.C.® therapy.The fungal infection was treated with antibiotics.No additional information was provided.A device history record review for the v.A.C.® granufoam¿ dressing lot number 9300889v009 and associated v.A.C.® drape was completed.All end release testing of the product and packaging met specifications.
Additional Manufacturer Narrative
The v.A.C.® drape was not returned; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged fungal infection requiring medication is related to the v.A.C.® drape.The patient left the v.A.C.® drape attached over night without active v.A.C.® therapy longer than the manufacturer's recommendation.Therefore, this event is being reported due to potential use error.A device history record review of the v.A.C.® granufoam¿ dressing and associated v.A.C.® drape met specifications.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.Precautions: the v.A.C.® therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area, untreated or inadequately treated infection, inadequate hemostasis of the incision, cellulitis of the incision area.Infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected 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.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.

• Brand Name: V.A.C.® DRAPE
• 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: 13348718
• Report Number: 3009897021-2022-00031
• Device Sequence Number: 19995061
• Product Code: OMP
• UDI-Device Identifier: 00849554000704
• UDI-Public: 010084955400070417240531109300889V009
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2022

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
• Device Expiration Date: 05/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 9300889V009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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: AFINITOR 7.5MG TAB AS DIRECTED ORALLY ONCE A DAY; EXEMESTANE 25MG TAB I TAB WITH A MEAL ORALLY ONCE; FENTANYL 25MCG/HR PATCH 1 PATCH TO SKIN TRANSDERMA; FIORICET 50-300-40MG CAP 1 CAP AS NEEDED ORALLY 4; FLEXERIL 5MG TAB ORALLY TID PRN; FOLIVANE-PLUS-CAP I CAP ORALLY ONCE A DAY; FULVESTRANT 250MG/5ML SOLUTION 10 IM; FULVESTRANT 250MG/5ML SOLUTION 10ML INTRAMUSCULAR; HYDROCODONE-ACETAMINOPHEN 10-325MG 1 TAB AS NEEDED; KISQALI (600MG DOSE), NOTES:600MG BID X 21 DAYS; LEVOTHYROXINE SODIUM 75 MCG TAB I TAB IN THE MORNI; LOMOTIL 2.5-0.025MG I TAB AS NEEDED ORALLY FOUR TI; LOPERAMIDE HCL 2 MG CAP I CAP AS NEEDED ORALLY FOU; MELATONIN 10MG TAB DISINTEGRATING AS DIRECTED ORAL; MEMANTINE HCCL 5MG TAB 1 TAB ORALLY ONE A DAY; MORPHINE SULFATE 15MG TAB 1 TABS NEEDED ORALLY EVE; ONDANSETRON HCL 4MG TAB I TAB ORALLY ONCE A DAY; REXULTI 2MG TAB 1 TAB ORALLY ONCE A DAY; SUMATRIPTAN 20MG/ACT 1 SPRAY AT ONSET OF HEADACHE; SUMATRIPTAN 5MG/ACT SOLUTION 1 SPRAY AT ONSET OF H; TRAZODONE HCL 150MG 1 TAB AT BEDTIME ORALLY ONCE A; TRINTELLIX 20MG 1 TAB ORALLY ONCE A DAY; TURMERIC CURCUMIN, NOTE: 22050MG; VITAMIN D-3 125 MCG (5000 UT) TAB AS DIRECTED ORAL; VYVANSE 50MG CAP 1 CAP ORALLY ONCE A DAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 89 KG