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

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI B097IMD006XL1), received between Aug 10, 2023 and Oct 21, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6)2024 THE PATIENT HAD THE DEVICE REMOVED DUE TO SCAR TISSUE FORMATION.

  Patient problems: Scar Tissue

  MAUDE report 20501204 ↗
• InjuryFeb 2, 2024Use of Device Problem; Use of Device Problem

  ON 11/19/2023, THE PATIENT CALLED THE PHYSICIAN'S OFFICE STATING DISSATISFACTION WITH THE LOOK OF HIS PENIS AND ALLEGING DEFORMITY.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Failure of Implant; Foreign Body Reaction; Scar Tissue

  MAUDE report 18631496 ↗
• InjuryAug 23, 2023Use of Device Problem; Use of Device Problem

  APPROXIMATELY 6 WEEKS AFTER IMPLANTATION, THE PATIENT DEVELOPED SEROMA. THE PATIENT REPORTED USING THE TANNING BED AND HYDROGEN PEROXIDE. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. IMD WAS MADE AWARE OF THIS EVENT BY (B)(6) FROM ADVANCED UROLOGY SEVERAL MONTHS AFTER THE EVENT OCCURRED.

  Patient problems: Seroma

  MAUDE report 17605152 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 2 WEEKS AFTER IMPLANTATION, THE PATIENT DEVELOPED SEROMA AND A DISPLACED IMPLANT. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2023. IMD WAS MADE AWARE OF THIS EVENT BY (B)(6) SEVERAL MONTHS AFTER THE EVENT OCCURRED.

  Patient problems: Seroma

  MAUDE report 17604225 ↗
• InjuryAug 15, 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 17549185 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE POST-OP PAIN AND MILD SWELLING.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 17512675 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  PATIENT COMPLAINED OF INFECTION, AND THE IMPLANT WAS REMOVED.

  Patient problems: Bacterial Infection

  MAUDE report 17501942 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  PATIENT COMPLAINED OF EROSION AND THE IMPLANT WAS REMOVED.

  Patient problems: Erosion

  MAUDE report 17501894 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  PATIENT COMPLAINED OF EROSION AND THE IMPLANT WAS REMOVED.

  Patient problems: Erosion

  MAUDE report 17501754 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  PATIENT COMPLAINED OF EROSION AND THE IMPLANT WAS REMOVED.

  Patient problems: Erosion

  MAUDE report 17501450 ↗