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

Model Number VACDSP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Rash (2033); Discomfort (2330); Skin Infection (4544); Drug Resistant Bacterial Infection (4553); Pyogenic Infection (4554)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Based on information provided, kci could not determine that the alleged events are related to the v.A.C.® drape.Neither a device history record review nor an evaluation of the v.A.C.® drape could be performed.The patient had ongoing issues with infection and abscess formation, previously confirmed unrelated to v.A.C.® therapy by the wound care nurse.Kci could not determine if the previous infections resolved.Device labeling, available in print and online, states: 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.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.

Event Description

On 13-apr-2021, the following information was reported to kci by the patient: on (b)(6) 2021, v.A.C.® therapy was placed on hold allegedly due to a reaction from the v.A.C.® drape.The patient's skin allegedly broke out in red bumps with white heads.The area around the wound was tweezed and the patient was placed on antibiotics.Additionally, the patient reported the skin was being pulled up with the v.A.C.® drape during dressing removal.On 07-may-2021, the following information was reported to kci by the wound care nurse: v.A.C.® therapy was placed on hold allegedly due to a sensitivity to the v.A.C.® drape and development of folliculitis to the periwound.The clinician tweezed the hair follicles and the patient was empirically started on antibiotics.On 13-may-2021, the following information was reported to kci by the wound care nurse: the wound was cultured on (b)(6) 2021, due to purulence noted from an area of the wound and based on the culture results, the patient was switched to a different antibiotic.No further information available.The v.A.C.® drape lot number was not provided and the device was not returned; therefore, a device history record review and a device evaluation could not be performed.

• Brand Name: V.A.C. DRAPE
• 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: 11823444
• MDR Text Key: 264597762
• Report Number: 3009897021-2021-00115
• 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: 05/13/2021

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
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/13/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR