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); Laceration(s) (1946)

Event Date 01/28/2021

Event Type  Injury  

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 and laceration requiring stitches is related to the v.A.C.® dressing.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 (b)(6) 2022, the following information was reported to kci via clinical records by the wound care center and reviewed: on (b)(6) 2021, "patient presents for wound vac dressing change to lle (lower left extremity).Also presents with laceration to rle (right lower extremity) s/p (status post) trip and fall.States [the patient] tripped and fell over the wound vac tubing.Laceration approx 8cm in length.Medial great toe abrasion 3cm in length.Rle laceration irrigated, applied steristrips and abd pad.Advised to go to maricamp er for imaging.Denies any headache." on (b)(6) 2021, "[the patient] has sustained a large laceration requiring stitches actually staples on the right lower leg upper 1/3 anterolateral part.[the patient] has also sustained a small abrasion on the medial aspect of the right foot 1st big toe." on (b)(6) 2022, the following information was reported to kci by the wound care nurse: the patient allegedly tripped over the v.A.C.® tubing.Patient saw the doctor and had sustained laceration which required staples.The patient's condition was fully checked by the physician.The v.A.C.® was suspended put on a hold just for safety purposes.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.

• 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: 13773006
• MDR Text Key: 290533344
• Report Number: 3009897021-2022-00058
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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: 02/18/2022
• 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: 64 YR
• Patient Sex: Male