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

Model Number VACDSP

Device Problem Insufficient Information (3190)

Patient Problem Fracture, Arm (2351)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

V.A.C.® dressing identifier was not provided and the dressing was not returned for evaluation.Additional information for activ.A.C.¿ ion progress¿ remote therapy monitoring system serial number (b)(4): unique identifier (udi) #: (b)(4), device manufacture date: 26-jul-2018.Based on information provided, it cannot be determined that the alleged trip and subsequent broken shoulder is related to the v.A.C.® dressing.The physician's nurse noted she was not aware of the reason for the fall, and the patient underwent surgery eight days post event.The physician noted v.A.C.® therapy was discontinued on (b)(6) 2020 as "goal of therapy met." 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.

Event Description

On 22-may-2020, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold.The patient allegedly tripped over the v.A.C.® tubing and broke his arm and shoulder which reportedly required emergency surgery.On 15-jun-2020, the following information was reported to kci by the physician's nurse: on (b)(6) 2020, the patient reportedly tripped and subsequently went to the emergency room.On (b)(6) 2020, a computerized tomography was performed, and the patient subsequently underwent an arthroplasty on (b)(6) 2020.The nurse was not aware of the reason for the fall but confirmed the patient is doing well.Per records review, on (b)(6) 2020, the physician noted v.A.C.® therapy was discontinued on (b)(6) 2020 as "goal of therapy met." on 28-dec-2019, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2020, the device was placed with the patient.On (b)(6) 2020, the device was tested per quality control procedure by kci quality engineering and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.The v.A.C.® dressing identifier was not provided and the product was not returned, therefore a device evaluation and device history review could not be performed.

• Brand Name: V.A.C. DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio, tx
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, tx ; 2556438
• MDR Report Key: 10168249
• MDR Text Key: 201092105
• Report Number: 3009897021-2020-00237
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063692
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 05/22/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR