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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cellulitis (1768)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

The v.A.C.® granufoam¿ dressing lot number was not provided, and the product was not returned; therefore, a device history record review and device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged cellulitis requiring antibiotics is related to the v.A.C.® granufoam¿ dressing.The patient has a history of complication.The physician indicated the duration between dressing changes may have contributed; therefore, this event is being reported due to potential use error.Device labeling, available in print and online, states: 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.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.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.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 21-nov-2022, the following information was reported to kci by the patient: the patient allegedly had a wound infection and started clindamycin.The wound was not infected prior to v.A.C.® therapy.On 12-dec-2022, the following information was provided by the physician: on (b)(6) 2022, the patient developed cellulitis of skin/tissue surrounding the wound.It was indicated the v.A.C.® granufoam¿ dressing may have contributed to the cellulitis due to use error, as the v.A.C.® granufoam¿ dressing had an odor when changed, likely due to duration between dressing changes (approximately 3 days).The infection was "easily treated with dressing changes and oral antibiotics".V.A.C.® therapy was continued throughout treatment and patient has fully recovered.The v.A.C.® granufoam¿ dressing lot number was not provided, and the product was not returned; therefore, a device history record review and device evaluation could not be performed.

• Brand Name: V.A.C.® GRANUFOAM¿ 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: 16004535
• MDR Text Key: 305707593
• Report Number: 3009897021-2022-00183
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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: 11/21/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female