SURGIMESH®EASYPLUG® TEALFIL-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700296900844), received between Aug 3, 2016 and Mar 8, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Contamination” (5 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2018Contamination; Contamination

  THE SURGEON IMPLANTED A SURGIMESH WN TEALFIL-8, USING THE PLUG PORTION ONLY, TO REPAIR THE PATIENT'S INGUINAL HERNIA ON (B)(6) 2015. THE WN TEAFIL-8 WAS REMOVED FROM STERILE PACKAGING IN THE OPERATING FIELD. ANTIBIOTICS WERE INITIATED FOR THE PATIENT ON (B)(6) 2016 DUE TO A DEVELOPING INFECTION. THE SURGEON REMOVED THE MESH ON (B)(6) 2017. THIS CASE IS ONE (1) OF FIVE (5) REMOVALS FOR INFECTION OUT OF APPROXIMATELY 530 OPEN INGUINAL REPAIRS (<1% INFECTION RATE) DONE BY THE SURGEON USING THE WN TEALFIL-8 MESH.

  Patient problems: Unspecified Infection

  MAUDE report 7325771 ↗
• InjuryMar 8, 2018Contamination; Contamination

  THE SURGEON IMPLANTED A SURGIMESH WN TEALFIL-8, PLUG PORTION ONLY, TO REPAIR THE PATIENT'S INGUINAL HERNIA ON (B)(6) 2015. THE WN TEALFIL-8 WAS TAKEN FROM A STERILE PACKAGE IN THE OPERATING FIELD. ANTIBIOTICS WERE INITIATED FOR THE PATIENT ON (B)(6) 2016 DUE TO A DEVELOPING INFECTION. THE SURGEON PARTIALLY REMOVED THE WN TEALFIL-8 PLUG ON (B)(6) 2016. THE REST OF THE WN TEALFIL-8 PLUG REMAINED IN THE PATIENT. THIS CASE IS ONE (1) OF FIVE (5) REMOVALS FOR INFECTION OUT OF APPROXIMATELY 530 OPEN INGUINAL REPAIRS (<1% INFECTION RATE) 08162016 DONE BY THE SURGEON USING THE WN TEALFIL-8 MESH.

  Patient problems: Unspecified Infection

  MAUDE report 7325765 ↗
• InjuryMar 8, 2018Contamination; Contamination

  THE SURGEON IMPLANTED A SURGIMESH WN TEALFIL-8, USING THE PLUG PORTION ONLY, TO REPAIR THE PATIENT'S RIGHT INGUINAL HERNIA ON (B)(6) 2016. THE WN TEALFIL-8 WAS TAKEN FROM A STERILE PACKAGE IN THE OPERATING FIELD. ANTIBIOTICS WERE INITIATED FOR THE PATIENT ON (B)(6) 2017 DUE TO A DEVELOPING INFECTION. ON (B)(6) 2017 THE SURGEON EXPLORED THE PATIENTS RIH REPAIR TO CLEAN-UP THE PATIENTS WOUND SITE. SUBSEQUENTLY THE SURGEON REMOVED THE MESH ON (B)(6) 2017. THIS CASE IS ONE (1) OF FIVE (5) REMOVALS FOR INFECTION OUT OF APPROXIMATELY 530 OPEN INGUINAL REPAIRS (<1% INFECTION RATE) DONE BY THE SURGEON USING THE WN TEALFIL-8 MESH.

  Patient problems: Unspecified Infection

  MAUDE report 7325761 ↗
• InjuryMar 8, 2018Contamination; Contamination

  THE SURGEON IMPLANTED A SURGIMESH WN TEALFIL-8 USING ONLY THE PLUG PORTION OF THE PRODUCT TO REPAIR THE PATIENT'S INGUINAL HERNIA ON (B)(6) 2016. THE WN TEALFIL-8 WAS TAKEN FROM A STERILE PACKAGE IN THE OPERATING FIELD. ANTIBIOTICS WERE INITIATED FOR THE PATIENT ON (B)(6) 2017 DUE TO A DEVELOPING INFECTION. THE SURGEON REMOVED THE MESH ON (B)(6) 2017. THE SURGEON NOTIFIED THE DISTRIBUTOR OF THIS EVENT ON (B)(6) 2017. THIS CASE IS ONE (1) OF FIVE (5) REMOVALS FOR INFECTION OUT OF APPROXIMATELY 530 OPEN INGUINAL REPAIRS DONE BY THE SURGEON USING THE WN TEALFIL-8 MESH.

  Patient problems: Unspecified Infection

  MAUDE report 7325751 ↗
• InjuryMar 8, 2018Contamination; Contamination

  THE SURGEON IMPLANTED A SURGIMESH WN TEALFIL-8, PLUG PORTION OF THE PRODUCT ONLY, TO REPAIR THE PATIENT'S INGUINAL HERNIA ON (B)(6) 2016. THE WN TEALFIL-8 WAS TAKEN FROM A STERILE PACKAGE IN THE OPERATING FIELD. ANTIBIOTICS WERE INITIATED FOR THE PATIENT ON (B)(6) 2017 DUE TO A DEVELOPING INFECTION. THE SURGEON REMOVED THE MESH ON (B)(6) 2017. THIS CASE IS ONE (1) OF FIVE (5) REMOVALS FOR INFECTION OUT OF APPROXIMATELY 530 OPEN INGUINAL REPAIRS (<1% INFECTION RATE) DONE BY THE SURGEON USING THE WN TEALFIL-8 MESH.

  Patient problems: Unspecified Infection

  MAUDE report 7325749 ↗
• InjuryAug 3, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DISTRIBUTOR REPORTED THAT : "PATIENT HAD A RIH REPAIR PERFORMED. FOUR MONTHS LATER WHEN PULLING UP CARPETING FELT THE AREA AROUND THE ORIGINAL SURGERY SITE GIVE WAY AND THEREAFTER WAS PAINFUL. THE PATIENT SOUGHT TREATMENT ABOUT A YEAR LATER FROM DOCTOR TO RELIEVE THE PAIN. AT EXPLORATION ONLY THE PLUG PORTION OF THE WN TEALFIL-8 HERNIA MESH WAS FOUND HEALED TO THE GENITAL AND FEMORAL BRANCHES OF THE GENITOFEMORAL NERVE. NO HERNIA DEFECT WAS FOUND AND NO OTHER MESH (THE PATCH PORTION OF THE WN TEALFIL-8) WAS IDENTIFIED UPON FURTHER EXPLORATION. THE PATIENT RECOVERED UNEVENTFULLY AND WAS DISCHARGED."

  Patient problems: Pain

  MAUDE report 5843356 ↗