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iTClamp® 9100Recalls & reported problems

Innovative Trauma Care Inc · The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp® is a self-locking trauma clamp with needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. · Class 2

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 00854874004004), received between Jul 17, 2017 and Jul 17, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Human Factors Issue” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Human Factors Issue1

Patient problems

  • Blood Loss1
  • Hematoma1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 17, 2017Human Factors Issue; Human Factors Issue

    IT WAS REPORTED THAT AN ITCLAMP WAS USED TO CONTROL EXTERNAL BLEEDING FROM A LACERATION IN THE JUNCTIONAL AREA OF A (B)(6) YEAR OLD MALE PATIENT. THE LACERATION CAUSED A COMPLETE TRANSECTION OF HIS FEMORAL ARTERY AND VEIN IN THE JUNCTIONAL AREA. UPON ARRIVAL AT THE EMERGENCY DEPARTMENT, IT WAS OBSERVED THAT THE BLEEDING WAS CONTINUING INTO THE INTERNAL SPACE RESULTING IN AN EXPANDING HEMATOMA. BLEEDING CONTROL WAS OBTAINED WITH DIRECT PRESSURE TO THE INGUINAL AREA. THE VOLUME OF BLOOD LOSS WAS POTENTIALLY LIFE-THREATENING. THE FEMORAL ARTERY AND VEIN WERE REPAIRED DURING SURGERY. NO FURTHER ISSUES WERE REPORTED.

    Patient problems: Blood Loss; Hematoma

    MAUDE report 6720492 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.