Himplant Pre-Formed Penile Silicone Block Extra Large - Semi SoftRecalls & reported problems
International Medical Devices, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B097IMD009XL1), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
Device problems
- Malposition of Device1
Patient problems
- Deformity/ Disfigurement1
- Erosion1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2023Malposition of Device; Malposition of Device
EVENT WAS DISCOVERED VIA EMAIL. THE PATIENT STATES HE RECEIVED A PENUMA IMPLANT AND THAT AFTER THE OPERATION HE EXPERIENCED EXTREME PAIN. HE ALLEGES THAT THE IMPLANT BROKE THROUGH THE SKIN, MAKING HIM UNABLE TO WALK WITHOUT SEVERE PAIN AND TO DRIP WHITE BLOOD PLASMA FROM HIS PENIS.
Patient problems: Deformity/ Disfigurement; Erosion; Pain; Unspecified Infection
MAUDE report 17098969 ↗
Other Elastomer, Silicone Block devices
- Himplant Pre-Formed Penile Silicone Block Extra Large - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block10 reports
- Himplant Pre-Formed Penile Silicone Block Large - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block9 reports
- Himplant Pre-Formed Penile Silicone Block Extra Large - Extra Long - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block7 reports
- Himplant Pre-Formed Penile Silicone Block Large - Extra Long - SoftInternational Medical Devices, Inc. · Elastomer, Silicone Block7 reports
- ContourFlex™ Gluteal Implant, Anatomical (Teardrop) Size 3Implantech Associates, Inc. · Elastomer, Silicone Block3 reports
- Gluteal Implant, Round, Textured, SDM Size: 14.9cm x 14.9cm x 3.9cmImplantech Associates, Inc. · Elastomer, Silicone Block2 reports
- ContourFlex™ Gluteal Implant, Round (Natural Contour) Size 3Implantech Associates, Inc. · Elastomer, Silicone Block2 reports
- ContourFlex™ Gluteal Implant, Anatomical (Teardrop) Size 2Implantech Associates, Inc. · Elastomer, Silicone Block2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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