MAUDE Adverse Event Report: LIFECELL 1 PACK REVOLVE FAT PROCESSING SYSTEM; SUCTION LIPOPLASTY SYSTEM

Catalog Number	RV0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported via sales representative that they have "done 10 fat grafting cases with revolve [at the hospital.] 3 of them at about the 2 week post op mark, have presented with inflammation and needed iv antibiotics.No fluid, just inflammation with redness." this is case 2 of 3.The device lot information and return status are unknown.
Additional Manufacturer Narrative
This event is being reported as serious injury due to the reported inflammation and infection with medical intervention.The other cases associated with this complaint are captured under abbvie complaint numbers: (b)(4).The lot associated with this event was not reported and remains unknown; therefore, a review into the device history records could not be performed.No revolve devices were returned for evaluation.Based on the limited information, and without relevant patient factors, a relationship between the event and the revolve could not be determined.Multiple follow-up attempts to the physician for additional information are ongoing.If additional information is made available, a supplemental report will be submitted.

• Brand Name: 1 PACK REVOLVE FAT PROCESSING SYSTEM
• Common Device Name: SUCTION LIPOPLASTY SYSTEM
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: marjorie alarcon ; 1 millennium way; branchburg, NJ 08876 ; 9089471504
• MDR Report Key: 21245784
• Report Number: 1000306051-2025-00005
• Device Sequence Number: 3573484
• Product Code: QKL
• UDI-Device Identifier: 00818410012267
• UDI-Public: 00818410012267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK220695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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 Catalogue Number: RV0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/27/2025
• 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 Sex: Unknown