MAUDE Adverse Event Report: LIFECELL UNKNOWN REVOLVE; LIPOASPIRATE WASHING SYSTEM FOR AESTHETIC BODY CONTOURING

Catalog Number	UNK REVOLVE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Addendum to d.4 lot number: 1180220.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported via company representative requesting a "credit for a defective revolve® system." the status of the device is unknown.Healthcare professional subsequently reported "felt as thought the mesh had a hole or the mesh was not on correctly and his fat was being sucked out of the bottom.Healthcare professional additionally reported "the issue was noted during the rinsing stage, when fat was noted in the waste container and not trapped in the revolve system for patient use.Approximately 400cc of fat was wasted." "the patient did not receive the full benefit of the procedure.".

• Brand Name: UNKNOWN REVOLVE
• Common Device Name: LIPOASPIRATE WASHING SYSTEM FOR AESTHETIC BODY CONTOURING
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 18328389
• Report Number: 1000306051-2023-10020
• Device Sequence Number: 15293286
• Product Code: QKL
• UDI-Device Identifier: 00818410012410
• UDI-Public: 818410012410
• 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
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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 Expiration Date: 02/28/2025
• Device Catalogue Number: UNK REVOLVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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