Himplant Pre-Formed Penile Silicone Block Extra Large - Extra Long - SoftRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B097IMD006XLO1), received between Aug 14, 2023 and Sep 11, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS INVOLVED IN A LAWSUIT, "PATIENT A AND PATIENT B V. INTERNATIONAL MEDICAL DEVICES.. ET AL." PATIENT B WAS ADDED TO THE LAWSUIT ON (B)(6) 2023. INTERNATIONAL MEDICAL DEVICE'S WAS MADE AWARE OF THIS ADDITION AND COMPLAINT ON 08/18/2023. PATIENT A AND PATIENT B ARE NAME PLACEHOLDERS FOR PATIENT CONFIDENTIALITY. COMPLAINT WAS DISCOVERED VIA EMAIL FROM A LAWYER'S OFFICE. THE OFFICE ATTACHED THE INFORMATION THAT INCLUDED THE EVENTS AND PATIENT INFORMATION. PATIENT B HAD A PENUMA DEVICE IMPLANTED IN (B)(6) 2019. AFTER THE OPERATION, THE PATIENT COMPLAINED OF UNNATURAL LOOK AND FEEL. HE ALSO STATED THAT HE HAD A CREASE ON BOTH SIDES OF HIS PENIS THAT WAS NOT AESTHETICALLY PLEASING. THE PATIENT ELECTED TO HAVE A SECOND SURGERY IN (B)(6) 2020. AFTER THE SECOND OPERATION, THE PATIENT STATED HE HAD A HOLE IN HIS PENIS WHICH FLUID LEAKED FROM. IN (B)(6) 2021, THE PATIENT HAD A THIRD SURGERY TO ADDRESS THE LEAKING FLUID. THE SURGEON REMOVED THE IMPLANT. FOLLOWING THE REMOVAL, THE PATIENT CLAIMED TO HAVE EXPERIENCED RETRACTION, LOSS OF SENSATION, AND SCARRING.

  Patient problems: Hyporesponsive to stimuli; Scar Tissue

  MAUDE report 17724032 ↗
• InjuryAug 24, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PATIENT HAD INITIAL DEVICE REMOVED AND UPGRADED TO A NEW DEVICE DUE TO SKIN EXPANSION AND STRETCHING.

  Patient problems: Wrinkling

  MAUDE report 17616587 ↗
• InjuryAug 23, 2023Use of Device Problem; Use of Device Problem

  THE PATIENT UNDERWENT REVISION FOR FLARING OF HIS PENUMA AS WELL AS VENTRAL PHALLOPLASTY ON (B)(6) 2022 AS HE HAD A VERY PROMINENT PENOSCROTAL WEBBING ((B)(6) 2022). THERE WAS SIGNIFICANT SKIN BREAKDOWN FROM HIS MID-PENILE INCISION SINCE THE SURGERY, DUE TO IMPROMPER UROWRAP USE, AND HE WAS EXPERIENCING INCREASED DRAINING AND SWELLING. THE PATIENT ALSO HAD A MID-SCROTAL SEPARATION AND A DEEP HOLE WITH SOME CLOTS, WITH NO SIGNS OF INFECTION. THERE WAS VENTRAL CURLING OF HIS PENIS FROM SCARRING AFTER THE SURGERY. THE PATIENT ALSO REPORTED THAT THERE WAS EXPOSURE OF THE DISTAL TIP OF THE IMPLANT CONCERNING FOR EROSION. THE DEVICE WAS EXPLANTED ON (B)(6) 2023. IMD WAS MADE AWARE OF THIS EVENT BY KRISTINA KLOSS FROM ADVANCED UROLOGY SEVERAL MONTHS AFTER THE EVENT OCCURRED.

  Patient problems: Erosion; Skin Erosion; Swelling/ Edema

  MAUDE report 17604417 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 6 WEEKS AFTER IMPLANTATION, THE IMPLANT ERODED AND WAS VISIBLE DISTALLY. THE DEVICE WAS EXPLANTED ON (B)(6) 2023. IMD WAS MADE AWARE OF THIS EVENT BY KRISTINA KLOSS FROM ADVANCED UROLOGY SEVERAL MONTHS AFTER THE EVENT OCCURRED.

  Patient problems: Erosion

  MAUDE report 17600539 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MILD PAIN AND MODERATE SWELLING/INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17542271 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE SWELLING AND POSSIBLE INFECTION.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 17542138 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE POST-OPERATIVE PAIN.

  Patient problems: Pain

  MAUDE report 17542084 ↗