MENTOR MemoryGel Breast Implant 3507175BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00081317000044), received between Aug 2, 2018 and Mar 17, 2025 — classified as 42 injuries.

The most frequently reported specific device problem is “Material Rupture” (25 reports).

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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21625828 ↗
• InjuryFeb 13, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL, 175CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURES DISCOVERED THROUGH ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. DURING A REINVESTIGATION INTO THE CASE, IT WAS IDENTIFIED THAT THE TWO DEVICES IN QUESTION WERE MISMATCHED PRODUCTS AND BELONG TO THIS FILE. RELEVANT DEVICE INFORMATION AND PRODUCT INVESTIGATION DETAILS HAVE BEEN TRANSFERRED FROM (B)(4) (BLIND UNIT) TO THIS COMPLAINT. NOTABLY, THE PATIENT INDICATED THAT THE IMPLANTS WERE IMPLANTED IN 1989, SUGGESTING THEY MAY NOT HAVE BEEN MANUFACTURED BY LEIDEN, WITH THE CORRECT PRODUCT CODES FOR BOTH IMPLANTS BEING 3507175BC, RATHER THAN 350-7175BC. FURTHER INVESTIGATION AND CLARIFICATION REGARDING THE PRODUCT CODES AND MANUFACTURING ORIGINS WILL BE NECESSARY. HIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21376654 ↗
• InjuryFeb 13, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL, 175CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURES DISCOVERED THROUGH ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. DURING A REINVESTIGATION INTO THE CASE, IT WAS IDENTIFIED THAT THE TWO DEVICES IN QUESTION WERE MISMATCHED PRODUCTS AND BELONG TO THIS FILE. RELEVANT DEVICE INFORMATION AND PRODUCT INVESTIGATION DETAILS HAVE BEEN TRANSFERRED FROM (B)(4) (BLIND UNIT) TO THIS COMPLAINT. NOTABLY, THE PATIENT INDICATED THAT THE IMPLANTS WERE IMPLANTED IN 1989, SUGGESTING THEY MAY NOT HAVE BEEN MANUFACTURED BY LEIDEN, WITH THE CORRECT PRODUCT CODES FOR BOTH IMPLANTS BEING 3507175BC, RATHER THAN 350-7175BC. FURTHER INVESTIGATION AND CLARIFICATION REGARDING THE PRODUCT CODES AND MANUFACTURING ORIGINS WILL BE NECESSARY. HIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21376627 ↗
• InjuryMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 175CC (LEFT) 200CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19293599 ↗
• InjuryMar 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 175CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18889907 ↗
• InjuryJul 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND A REACTION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON MONTH XX, 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17430494 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH 175CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08910 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17424602 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH 175CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08909 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17424599 ↗
• InjuryJul 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53 YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY FOR AN UNDISCLOSED REASON. DURING THE PROCEDURE, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 170CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08680 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17373586 ↗
• InjuryJul 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY FOR AN UNDISCLOSED REASON. DURING THE PROCEDURE, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 170CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08681 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17373585 ↗
• InjuryMay 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 175CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY; CONFIRMED WITH MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16983515 ↗
• InjuryMay 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 175CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY; CONFIRMED WITH MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16983513 ↗
• InjuryApr 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE LEFT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST AND THERE IS REDNESS ON THE BOTTOM OF THE BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16824894 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, 175CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE II POST PROCEDURE. THE DOCTOR EXAMINATION CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 15580787 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 175CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE III-IV POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE VISITATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15464884 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING SHORTNESS OF BREATH, DIFFICULTY BREATHING, SWOLLEN FOOT, SWOLLEN THYROID, FATIGUE, DEPRESSION, AND ASYMMETRY POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15095858 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 175 CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING SHORTNESS OF BREATH, DIFFICULTY BREATHING, SWOLLEN FOOT, SWOLLEN THYROID, FATIGUE, DEPRESSION, AND ASYMMETRY POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15095839 ↗
• InjuryJun 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRAD 3-4 AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 14648334 ↗
• InjuryApr 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT AFTER AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 250CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14196488 ↗
• InjuryApr 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT STATED THAT HER LEFT BREAST APPEARED SMALLER, AND THAT THE VOLUME HAD DECREASED. ADDITIONALLY, SHE HAD MAMMOGRAM IMAGING CONDUCTED AND THE LEFT BREAST AND THE LEFT BREAST IMPLANT WERE DESCRIBED AS CRINKLING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14017203 ↗
• InjuryFeb 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. AN ULTRASOUND INDICATED RUPTURE OF THE LEFT BREAST PROSTHESIS. THE RUPTURE WAS LATER DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13529907 ↗
• InjuryAug 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 175 CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND A REACTION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 12289878 ↗
• InjuryApr 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH 350CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV. UPON BILATERAL REMOVAL SURGERY ON (B)(6) 2020, THE RIGHT SIDE BREAST IMPLANT WAS FOUND TO BE RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 11721855 ↗
• InjuryFeb 2, 2021Material Discolored; Material Rupture; Material Discolored; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDE BREAST IMPLANT RUPTURE AND DISCOLORATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED VIA PHYSICAL EXAM. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2021. THE CUSTOMER REPORTED THE DEVICE APPEARED DISCOLORED POST EXPLANTATION. THIS IS NOT THE PRIMARY REASON FOR EXPLANTATION. THE POTENTIAL THAT THIS ISSUE COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS COMPLAINT IS BEING REPORTED PRIMARILY DUE TO THE BREAST IMPLANT RUPTURE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11267214 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO UNSPECIFIED MENTOR MEMORY GEL XTRA BREAST IMPLANTS ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11085135 ↗