MENTOR SILTEX CONTOUR PROFILE High 3542712Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00081317001911), received between Feb 8, 2018 and Dec 26, 2025 — classified as 74 injuries.

The most frequently reported specific device problem is “Material Rupture” (50 reports).

2 other recalls cover devices cleared under the same FDA submission (P990075); they may or may not involve this specific model.

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 74 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23899065 ↗
• InjuryJan 6, 2025Material Rupture; Material Rupture

  A REPORT HAS NOTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 350 CC SALINE PROSTHESIS EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION, WHICH WAS DIAGNOSED THROUGH A PHONE CALL WITH THE PATIENT. AS OF THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION CONCERNING EXPLANTATION OR AN ANTICIPATED DATE FOR THE EXPLANTATION PROCEDURE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21083137 ↗
• InjurySep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR SALINE IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20274860 ↗
• InjuryApr 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA IN-OFFICE EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19081167 ↗
• InjuryJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A WHITE FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE BREAST PROSTHESES DEVELOPED ISSUES WITH BOTH OF HER BREAST PROSTHESES POST IMPLANTATION. IT WAS REPORTED THAT THE BREAST PROSTHESES WERE LEAKING AND THAT THE BREASTS ARE ¿RIPPLY, BUBBLY, FEELS LIKE MARBLES INSIDE FOR A LONG PERIOD OF TIME¿. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT BREAST WAS INFLAMED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 17270344 ↗
• InjuryJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A WHITE FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE BREAST PROSTHESES DEVELOPED ISSUES WITH BOTH OF HER BREAST PROSTHESES POST IMPLANTATION. IT WAS REPORTED THAT THE BREAST PROSTHESES WERE LEAKING AND THAT THE BREASTS ARE ¿RIPPLY, BUBBLY, FEELS LIKE MARBLES INSIDE FOR A LONG PERIOD OF TIME¿. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT BREAST WAS INFLAMED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17270341 ↗
• InjuryJan 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 38-YEAR-OLD WHITE HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16210592 ↗
• InjuryMay 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT STATED THAT HER LEFT BREAST WAS LEAKING SPONTANEOUSLY. THE REPORTED EVENT IS CONSISTENT WITH A DEFLATED BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14515846 ↗
• InjuryApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 350CC MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14226735 ↗
• InjuryApr 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS AND EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO SIENTRA GEL BREAST IMPLANTS ON (B)(6) 2022. THE PATIENT WAS FULLY RECOVERED AFTER THE REVISION SURGERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13992622 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE HIGH, 350CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT#: 3503754BC, SN#: (B)(4), R/ CAT#: 3503754BC, SN#: (B)(4) ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13593758 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE HIGH, 350CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT#: 3503754BC, SN#: (B)(4), R/ CAT#: 3503754BC, SN#: (B)(4) ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13593640 ↗
• InjuryFeb 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A (B)(6) PROFILE HIGH AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION, AND REPLACEMENT WITH CATALOG NUMBER 3502425; SERIAL NUMBER (B)(4)ON THE LEFT SIDE; AND WITH CATALOG NUMBER 3502425; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13535422 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES AND EXPERIENCED AUTOIMMUNE SYMPTOMS INCLUDING FIBROMYALGIA 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: Autoimmune Disorder

  MAUDE report 13345440 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES AND EXPERIENCED AUTOIMMUNE SYMPTOMS INCLUDING FIBROMYALGIA 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: Autoimmune Disorder

  MAUDE report 13345393 ↗
• InjuryJul 13, 2021Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND A DEVICE MIGRATION ON THE LEFT SIDE 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: Capsular Contracture

  MAUDE report 12163316 ↗
• InjuryJul 13, 2021Adverse 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 SURGERY WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND A DEVICE MIGRATION ON THE LEFT SIDE 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: Capsular Contracture

  MAUDE report 12163312 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD WHITE HISPANIC FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS RIGHT BREAST IMPLANT DEFLATION AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNKNOWN), POST-PROCEDURE. THE RIGHT BREAST DEFLATION WAS INITIALLY SELF-DIAGNOSED BY THE PATIENT AND WAS ALSO DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT. THE RIGHT CAPSULAR CONTRACTURE WAS DIAGNOSED DURING THE REVISION SURGERY ON (B)(6) 2021. THE PATIENT SUBSEQUENTLY UNDERWENT BILATERAL COMPLETE CAPSULECTOMIES AND BILATERAL REMOVAL AND REPLACEMENT OF THE IMPLANTS. THE REPLACEMENT DEVICES WERE THE FOLLOWING: (RIGHT) 225CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501630 LOT: 9556176 SN: (B)(4) AND (LEFT) 225CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501630 LOT: 9534032 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12155903 ↗
• InjuryJul 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD WHITE HISPANIC FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS RIGHT BREAST IMPLANT DEFLATION AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNKNOWN), POST-PROCEDURE. THE RIGHT BREAST DEFLATION WAS INITIALLY SELF-DIAGNOSED BY THE PATIENT AND WAS ALSO DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT. THE RIGHT CAPSULAR CONTRACTURE WAS DIAGNOSED DURING THE REVISION SURGERY ON (B)(6) 2021. THE PATIENT SUBSEQUENTLY UNDERWENT BILATERAL COMPLETE CAPSULECTOMIES AND BILATERAL REMOVAL AND REPLACEMENT OF THE IMPLANTS. THE REPLACEMENT DEVICES WERE THE FOLLOWING: (RIGHT) 225CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501630 LOT: 9556176 SN: (B)(4) AND (LEFT) 225CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501630 LOT: 9534032 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12155902 ↗
• InjuryMay 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD WHITE FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SILTEX CONTOUR PROFILE HIGH AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT LEFT SIDE EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3504004BC; SERIAL NUMBER (B)(4) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11825632 ↗
• InjuryMay 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES, SUFFERED RIGHT BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE DEFLATION WAS DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR IMPLANT EXPLANTATION SURGERY ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11766627 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SSILTEX CONTOUR PROFILE HIGH 350CC SALINE PROSTHESIS EXPERIENCED BILATERAL RIPPLING POST PROCEDURE. THE PATIENT STATED THAT THE FORM HAS CHANGE AND DON'T LOOK THE SAME AND THEY FEEL TIGHTENING AND HAD AN MRI EXAMINATION AND THERE WERE FINDINGS OF RIPPLING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; Wrinkling

  MAUDE report 11694982 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE PROSTHESIS EXPERIENCED BILATERAL RIPPLING POST PROCEDURE. THE PATIENT STATED THAT THE IMPLANTS FORM HAS CHANGE AND DON'T LOOK THE SAME AND THEY FEEL TIGHTENING AND HAD AN MRI EXAMINATION AND THERE WERE FINDINGS OF RIPPLING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; Wrinkling

  MAUDE report 11694938 ↗
• InjuryFeb 17, 2021Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 350CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS (SERIAL NUMBERS (B)(4)) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11338251 ↗
• InjuryDec 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 350CC SALINE MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. THE DEFLATION WAS CONFIRMED WITH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11084888 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.

• Z-0367-2022 · Sep 30, 2021 · Open, Classified
  MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048