MAUDE Adverse Event Report: MENTOR TEXAS COLEMAN 16G 15CM LL CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	COL-I16B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s reference number: (b)(4).Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for reoperation: reoperation under general anesthesia took place as a result of the adverse event of chronic seroma that occurred immediately post surgery reported.(b)(4).Mentor's manufacturer's report numbers: 1645337-2020-11861, 1645337-2020-11863, 1645337-2020-11865, 1645337-2020-11868, 1645337-2020-11869, 1645337-2020-11871, 1645337-2020-11872.Are related to the same incident.
Event or Problem Description
This complaint is from a literature source.It was reported that 1 patient underwent immediate fat grafting for latissumus dorsi only breast reconstruction and suffered chronic seroma in the donor site.Intervention was reoperation under general anesthesia.This reported event occurred immediately after the procedure.Additional information was received from the corresponding author on 09/08/2020 stating the reported patient consequences were attributed to the procedure and not to the medical devices used.However, assignment of the root cause for the event remains inconclusive and therefore a 3500a will be submitted out of an abundance of caution.Other mentor devices that were also used in this study: none.Non-mentor devices that were also used in this study: mercedes-type cannula (3 mm 932 cm), b-braun 10cc syringes, thermo scientific fixed-rotor centrifuge.Publication details: title: safety of large-volume immediate fat grafting for latissimus dorsi-only breast reconstruction: results and related complications in 95 consecutive cases.Objective: to study if breast reconstruction using latissimus dorsi and immediate fat grafting (lifg) is a widely applicable technique for those cases in which an autologous reconstruction is desirable, but the use of microsurgical perforator flaps is not available.Methods: data of 95 consecutive breast reconstructions from (b)(6) 2014 to (b)(6) 2018 were prospectively collected.All patients included in the study had a minimum follow-up of one year after completion of the reconstructive process.

• Brand Name: COLEMAN 16G 15CM LL CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10581118
• Report Number: 1645337-2020-11864
• Device Sequence Number: 19573588
• Product Code: MUU
• UDI-Device Identifier: 00081317020189
• UDI-Public: 00081317020189
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K981172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: COL-I16B
• Device Catalogue Number: COL-I16B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B-BRAUN 10CC SYRINGES; MERCEDES-TYPE CANNULA; THERMO SCIENTIFIC FIXED-ROTOR CENTRIFUGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR