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

Model Number VACDSP

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

Patient Problems Fall (1848); Head Injury (1879); Intracranial Hemorrhage (1891)

Event Date 01/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was reported to kci by the home health nurse: on (b)(6) 2022, the patient tripped and fell due to the activ.A.C.¿ ion progress¿ remote therapy monitoring system and reported to the emergency room.On (b)(6) 2022, the following information was reported to kci via clinical records: on (b)(6) 2022, "62-year-old female who presents as a non-active trauma status post mechanical fall from standing, - loc (level of consciousness), +asa (acetylsalicylic acid).Patient without c collar and place.Patient elevated using a tls protocol.Airway intact, bilateral breath sounds present, hemodynamically stable, peripheral pulses intact, gcs (glasgow coma scale) 15 ((b)(6)).Patient complaining primarily of left hip pain.She denies any headache, lightheadedness, chest pain, shortness of breath, paresthesia, abdominal pain, nausea, or vomiting.She denies neck pain or back pain.She states she recently had a "clot" drained from her right thigh and has a wound vac, which she tripped on and fell backwards today she has fallen three times over the last year.She is not sure why she keeps falling.Per chart review, patient was recently admitted at memorial and underwent draining of a right thigh abscess with wound vac placement.".Patient was admitted for observation with a diagnosis of acute subarachnoid hemorrhage.On (b)(6) 2022, the following information was reported to kci by the patient's family member: the patient was confused due to patient's kidneys and liver failing.The patient stood up in a daze and fell over the v.A.C.® tubing.The v.A.C.® dressing lot number was not provided, and the device was not returned; therefore, a device history record review and device evaluation could not be performed.

Manufacturer Narrative

The v.A.C.® dressing lot number was not provided, and the device 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 fall is related to the v.A.C.® dressing.The patient reportedly has a history of falling and was disoriented due to multiple comorbidities.Device labeling, available in print and online, states: carrying case: use the adjustable strap to wear the carrying case across your chest.Keep the therapy unit in the carrying case when in use.Tubing storage straps are provided.Fall prevention tips: follow these safety tips to help prevent slips or falls while using the v.A.C.® therapy system: know your surroundings.Avoid possible tripping hazards, such as throw rugs, extension cords, and uneven floors.Safely store and secure any excess power cord and tubing to prevent tripping.See the therapy unit user manual for how to properly secure tubing.Be cautious of door knobs and other household objects that could catch exposed tubing.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.

• 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: 13971244
• MDR Text Key: 292521195
• Report Number: 3009897021-2022-00075
• 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: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• 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: ALBUTEROL 90 MCG/INH INHALATION AEROSOL; ASPIRIN ECCENTRIC COATED 81 MILLIGRAMS, ORAL, DAIL; ATORVASTATIN 40 MILLIGRAMS, ORAL, DAILY; DULOXETINE DELAYED RELEASE CAP 60 MG ONE CAP, ORAL; FOLIC ACID 1 MG, ORAL, DAILY; GABAPENTIN 600 MG ONE TABLET, ORAL, DAILY THREE TI; INSULIN DETEMIR 100 UNITS/ML SQ 17 UNITS QHS; KEFLEX 500 MILLIGRAMS CAPSULE ONE CAP, ORAL, TID; METOPROLOL SUCCINATE ER 25 MG ORAL TABLET, DAILY; NOVOLOG FLEXPEN 100 UNITS/ML INJECTABLE SOLUTION; OMEPRAZOLE 20 MG ONE TAB, ORAL, DAILY; REQUIP 3 MG, ORAL, EVERYDAY AT BEDTIME; ROXICODONE ONE 5 MG ORAL TABLET ONE TAB, PRN, DAIL; TRAMADOL 50 MG ORAL TABLET EVERY SIX HOURS
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female