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

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B097IMD006LLO1), received between Aug 2, 2023 and Dec 8, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2023Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

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

  Patient problems: Hematoma; Unspecified Tissue Injury

  MAUDE report 18291768 ↗
• InjuryDec 1, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  EVENTS WERE DISCOVERED WHEN LAWSUIT "(B)(6) 12 PLAINTIFF VS INTERNATIONAL MEDICAL DEVICES.. ET AL" WAS PROVIDED TO THE QUALITY TEAM. THE LAWSUIT CLAIMS THAT THIS PATIENT HAD COMPLICATIONS AS A RESULT OF RECEIVING A PENUMA IMPLANT. (B)(6) 12 WAS IMPLANTED WITH THE PENUMA IMPLANT IN (B)(6) 2021. THE PATIENT STATED THAT AFTER IMPLANTATION HE EXPERIENCED PAIN, CURVATURE, AND IMPLANT PROTRUSION. THE PATIENT HAD A REVISION SURGERY (B)(6) 2022. AFTER THE REVISION SURGERY, THE PATIENT STATED HE STILL EXPERIENCED PAIN, CURVATURE, AND PROTRUSION. THE PATIENT HAD THE IMPLANT REMOVED ON (B)(6) 2022. AFTER REMOVAL, THE PATIENT STATES HE EXPERIENCED SWELLING, LOSS OF SENSATION, NERVE DAMAGE, NUMBNESS, CURVATURE, LOSS OF LENGTH, PAIN, SCARRING, ERECTILE DYSFUNCTION, PENILE SHORTENING, REDUCED SEXUAL ACTIVITY AND DEPRESSION.

  Patient problems: Deformity/ Disfigurement; Depression; Failure of Implant; Hyporesponsive to stimuli; Implant Pain; Nerve Damage; Numbness; Scar Tissue; Sexual Dysfunction; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 18250646 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DESIRED REMOVAL OF THE IMPLANT. A HEMATOMA WAS EVACUATED. THE DEVICE WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Hematoma

  MAUDE report 17617384 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE PAIN AND SWELLING/INFLAMMATION.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 17549245 ↗
• 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 17541837 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF MODERATE SWELLING AND DISSATISFACTION WITH COSMETIC RESULT.

  Patient problems: Swelling/ Edema

  MAUDE report 17515405 ↗
• InjuryAug 2, 2023Use of Device Problem; Use of Device Problem

  EVENTS WERE DISCOVERED ON 07/06/2023 FROM A PROPUBLICA ARTICLE (PUBLISHED ON 06/26/2023). AN ARTICLE TITLED "INSIDE THE SECRETIVE WORLD OF PENILE ENLARGEMENT" STATED THAT SEVERAL PATIENTS HAD COMPLICATIONS AS A RESULT OF RECEIVING A PENUMA IMPLANT. THE ARTICLE LISTS SEVERAL DIFFERENT PATIENTS AND THEIR EXPERIENCES. THIS REPORT WILL CAPTURE THE EVALUATION OF "MICK" (NAME GIVEN IN ARTICLE). FOLLOWING THE IMPLANTATION, THE PATIENT STATES HE EXPERIENCED PAINFUL MORNING ERECTIONS, EROSION ON THE CORNERS, LOSS OF SENSITIVITY, LOSS OF LENGTH, AND DEPRESSION. THE INTERNATIONAL MEDICAL DEVICES TEAM BELIEVES WE HAVE IDENTIFIED THE EXACT PATIENT DUE TO THE IMPLANTATION DATE AND CORRESPONDENCE WITH THE CLINIC.

  Patient problems: Depression; Erosion; Hyporesponsive to stimuli; Pain

  MAUDE report 17445547 ↗