Coleman Infiltration-Style I 16ga x 15cm Cannula, Body COL-I16BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317020189), received between Sep 24, 2020 and Sep 24, 2020 — classified as 8 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 12 PATIENTS UNDERWENT IMMEDIATE FAT GRAFTING FOR LATISSUMUS DORSI ONLY BREAST RECONSTRUCTION AND SUFFERED OIL CYSTS. INTERVENTION WAS NOT REPORTED. THIS REPORTED EVENT OCCURRED DURING FOLLOW UP (~ 6-12 MONTHS 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 AUTO

  Patient problems: Cyst(s)

  MAUDE report 10581189 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 5 PATIENTS UNDERWENT IMMEDIATE FAT GRAFTING FOR LATISSUMUS DORSI ONLY BREAST RECONSTRUCTION AND SUFFERED PARTIAL NECROSIS. NO INTERVENTION WAS REPORTED. 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 RECONSTRUC

  Patient problems: Necrosis

  MAUDE report 10581171 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 3 PATIENTS UNDERWENT IMMEDIATE FAT GRAFTING FOR LATISSUMUS DORSI ONLY BREAST RECONSTRUCTION AND SUFFERED FAT NECROSIS. PERCUTANEOUS BIOPSIES WERE PERFORMED CONFIRMING THE DIAGNOSIS OF FAT NECROSIS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORRESPONDING AUTHOR ON (B)(6) 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. THIS REPORTED EVENT OCCURRED DURING FOLLOW UP ( ~ 6-12 MONTHS AFTER THE PROCEDURE). 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 APPLI

  Patient problems: Necrosis; No Code Available

  MAUDE report 10581161 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 6 PATIENTS UNDERWENT IMMEDIATE FAT GRAFTING FOR LATISSUMUS DORSI ONLY BREAST RECONSTRUCTION AND SUFFERED DONOR SITE WOUND DEHISCENCE. SURGICAL INTERVENTION WAS NOT REPORTED. THIS REPORTED EVENT OCCURRED IMMEDIATELY AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORRESPONDING AUTHOR ON (B)(6) 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 AU

  Patient problems: Impaired Healing

  MAUDE report 10581141 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 2 PATIENTS UNDERWENT IMMEDIATE FAT GRAFTING FOR LATISSIMUS DORSI ONLY BREAST RECONSTRUCTION AND SUFFERED PARTIAL NECROSIS IN THE SKIN ISLAND OF THE FLAP REQUIRING DEBRIDEMENT AND SUTURE. 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 UTILIZED. 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 CASE

  Patient problems: Necrosis; No Code Available

  MAUDE report 10581131 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 THOS

  Patient problems: No Code Available; Seroma

  MAUDE report 10581118 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 WOUND DEHISCENCE. SURGICAL INTERVENTION TOOK PLACE BUT NOT SPECIFIED. 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

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10581113 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 8 PATIENTS UNDERWENT IMMEDIATE FAT GRAFTING FOR LATISSIMUS DORSI ONLY BREAST RECONSTRUCTION AND SEROMA IN THE LATISSIMUS DORSI DONOR SITE. INTERVENTION WAS ASPIRATION. 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 AUTOL

  Patient problems: No Code Available; Seroma

  MAUDE report 10581075 ↗