TABOTAMP FIBRILLAR 431963Recalls & reported problems
Ethicon, LLC · Class 3 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031005372), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. UPON OPENING THE SEALED ABSORBABLE HEMOSTAT, THEY DISCOVERED A HAIR INSIDE THE ENCLOSED PAPER PACKAGING, AND IT APPEARS TO BE WITHIN THE MESH OF THE ABSORBABLE HEMOSTAT. THE SURGERY WAS DELAYED BY THREE MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT IMPACT, AND A NEW ABSORBABLE HEMOSTAT WAS OBTAINED AND USED WITHOUT ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16539724 ↗
Other Agent, absorbable hemostatic, non-collagen based devices
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- SURGICEL FIBRILLAR 1961Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall2 deaths120 reports
- SURGICEL FIBRILLAR 1963Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall44 reports
- SURGICEL 1953Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based56 reports
- SURGICEL 1952Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 death41 reports
- SURGICEL FIBRILLAR 1962Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based35 reports
- Veriset HP0510ECovidien LP · Agent, Absorbable Hemostatic, Non-Collagen Based1 death33 reports
- SURGICEL SNoW 2082Ethicon, LLC · Agent, absorbable hemostatic, non-collagen based24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.