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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI B097IMD006L1), received between Aug 10, 2023 and Jan 22, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/23/2023, THE PATIENT REPORTED SEVERE SWELLING IN THE PENIS THAT BEGAN FOUR WEEKS PRIOR. THE PATIENT ELECTED TO HAVE THE IMPLANT REMOVED.

  Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 18552655 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE SWELLING AND INFLAMMATION.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 17549106 ↗
• 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 17543924 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE SWELLING AND INFLAMMATION.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 17541767 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE SWELLING AND PAIN AT INCISION LINE.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 17541655 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE, POST-OPERATIVE SWELLING.

  Patient problems: Swelling/ Edema

  MAUDE report 17506182 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE SWELLING AND INFLAMMATION AFTER THE PROCEDURE.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 17506104 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE PAIN AND DISSATISFACTION WITH AESTHETIC RESULT.

  Patient problems: Implant Pain

  MAUDE report 17506007 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE POST-OP PAIN.

  Patient problems: Implant Pain

  MAUDE report 17505911 ↗