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

Model Number VACDSP

Device Problem Insufficient Information (3190)

Patient Problems Bowel Perforation (2668); Insufficient Information (4580)

Event Date 12/29/2020

Event Type  Death  

Manufacturer Narrative

Date of event: the specific date is unknown.Per kci records, the last date of therapy for this patient is (b)(6) 2020.Device type and identifier were not provided.Based on information provided, it cannot be determined that the alleged colon damage, surgeries and subsequent death were related to the v.A.C.® dressing.The v.A.C.® dressing type and identifier were not provided, therefore, kci cannot perform a device history record review or device evaluation.Per clinical records, the patient had a lengthy history of abdominal surgeries and complications requiring hospitalizations and surgical revisions.Prior to v.A.C.® therapy placement, the patient was on antibiotic therapy due to ventral hernia repair infection complications and persistent fluid collection/abscess.Kci is making additional attempts to obtain clinical information.Device labeling, available in print and online, states: warnings: protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Always ensure that v.A.C.® foam dressings do not come in direct contact with vessels or organs.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.

Event Description

On 11-mar-2021, the following information was provided to kci by the patient's spouse: in late (b)(6), the patient reportedly went to the emergency room due to the incorrect "sponges" being delivered which allegedly caused damaged to the patient's colon.The patient underwent two emergency surgeries and subsequently passed away (date unknown) as a result of that.No additional information is available.Records review noted the following: on (b)(6) 2020, the patient was admitted to the hospital due to post-operative complications.Patient was started on v.A.C.Veraflo¿ instillation therapy using the v.A.C.Ulta¿ therapy system with v.A.C.Whitefoam¿ dressing and v.A.C.® granufoam¿ dressing.It was noted v.A.C.® dressing was to be changed every four days.It was noted the patient was feeling better and was to continue antibiotic regimen.On (b)(6) 2020, it was noted the patient was feeling better and the wound vac is working properly.The v.A.C.® therapy system type and identifier were not provided; therefore, a device evaluation could not be performed.The v.A.C.® dressing type and lot number was not provided; therefore, a device history record review could not be performed.

Manufacturer Narrative

Based on the information provided, kci's assessment remains the same; it cannot be determined that the alleged colon damage, surgeries and subsequent death were related to the v.A.C.® dressing.The v.A.C.® dressing type and identifier were not provided, therefore, kci cannot perform a device history record review or device evaluation.Per clinical records, the patient had a lengthy history of abdominal surgeries and complications requiring hospitalizations and surgical revisions.Prior to v.A.C.® therapy placement, the patient was on antibiotic therapy due to ventral hernia repair infection complications and persistent fluid collection/abscess.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.The cause of the patient's death could not be established.

• Brand Name: V.A.C. DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 11646375
• MDR Text Key: 244800451
• Report Number: 3009897021-2021-00071
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPICILLIN SODIIUM/SULBACTAM 3 GM IV Q6H.; VANCOMYCIN.; ZOYSN.; AMPICILLIN SODIIUM/SULBACTAM 3 GM IV Q6H; VANCOMYCIN; ZOYSN
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 73 YR
• Patient Weight: 62