MAUDE Adverse Event Report: KINETIC CONCEPTS, INC V.A.C.® GRANUFOAM¿ DRESSING; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	M8275052
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the following information was provided by the patient: the v.A.C.® granufoam¿ dressing was too long, and she had to clip it to her pants.The tubing detached from her pants and entangled around the tire of her husband¿s car causing her to fall.As a result of the fall, she sustained a laceration to her forehead that required sutures and suffered a fractured shoulder.She subsequently underwent surgical intervention for the shoulder injury.No additional information was provided.On (b)(6) 2025, a device history record review for the v.A.C.® granufoam¿ dressing lot number c21005v009 was completed.All end release testing of product and packaging met specifications.
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged event was related to the v.A.C.® granufoam¿ dressing tubing.The patient has a history of neuropathy, and the wound is located on the right foot.Multiple unsuccessful attempts have been made to obtain additional clinical information.All end release testing of product and packaging met specifications.The patient did not properly store and secure excess tubing using the tubing storage straps in the carrying case as indicated in device labeling; therefore, this event is being reported due to potential use error.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 doorknobs 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.® GRANUFOAM¿ DRESSING
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 23314735
• Report Number: 3009897021-2025-00049
• Device Sequence Number: 14900163
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 01008495540020981728022810C
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M8275052
• Device Catalogue Number: M8275052
• Device Lot Number: C21005V009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female