Himplant Pre-Formed Penile Silicone Block Extra Extra Large - 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 B097IMD006XXL1), received between Aug 15, 2023 and Aug 15, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT COMPLAINED OF SWELLING AND INFLAMMATION (MODERATE).
Patient problems: Inflammation; Swelling/ Edema
MAUDE report 17549213 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page