SURGICEL 1955Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031003064), received between Sep 8, 2018 and Jan 19, 2021 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION SURGERY ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS PLACED NEXT TO THE DURA. THE SIZE OF THE ABSORBABLE HEMOSTAT WAS ABOUT 1 × 4 CM, AND IT WAS PLACED AT L4-5. A POSTOPERATIVE CT SCAN SHOWED THAT THERE WAS SOMETHING WHICH SEEMED TO BE CALCIFIED. THE PATIENT DID NOT EXPERIENCE PARALYSIS, BUT THE PATIENT HAS NERVE DISORDERS SUCH AS PAIN. THE SYMPTOM WAS BEING TREATED WITH MEDICINE. SINCE 14 DAYS HAVE PASSED, THE SURGEON AS CONSIDERING IF REOPERATION WAS NECESSARY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Numbness; Pain

  MAUDE report 11197732 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOTOMY PROCEDURE ON (B)(6) 2020 AND THE SURGEON WAS HAVING TROUBLE ACHIEVING HEMOSTASIS WITH A VESSEL AND APPLIED AN ABSORBABLE HEMOSTAT TO ACHIEVE HEMOSTASIS. TWENTY-FOURS POST OP, THE PATIENT WASN'T ABLE TO MOVE OR FEEL THEIR LOWER EXTREMITIES. THE DOCTOR THOUGHT THE PATIENT HAD A HEMATOMA, TOOK THE PATIENT BACK TO SURGERY AND REALIZED THE ABSORBABLE HEMOSTAT WAS ON THE SPINAL COLUMN, COMPRESSING THE SPINAL CORD. THE DOCTOR REMOVED THE ABSORBABLE HEMOSTAT FROM THE PATIENT AND THE PATIENT IS BEING MONITORED. AS OF TODAY, THE PATIENT IS STILL IN THE HOSPITAL AND STILL HASN'T REGAINED MOVEMENT OR FEELING IN THEIR LOWER EXTREMITIES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Paralysis

  MAUDE report 9944539 ↗
• InjurySep 8, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. ONE WEEK LATER, THE PATIENT NOTICED A SKIN IRRITATION. THE IRRITATION IS LIMITED TO THE BORDER OF THE BANDAGE. THE PATIENT WAS GIVEN A LOW LEVEL STEROID CREAM WHICH SLIGHTLY REDUCED THE ITCHING. THE WHOLE SITE IS STILL RED. THE PATIENT HAS SEEN A PHYSICIAN AND A DERMATOLOGIST. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Irritation

  MAUDE report 7858647 ↗