NA 0400820000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540152688), received between May 30, 2018 and Dec 11, 2018 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, A TEAR WAS FOUND ON THE TOGA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153752 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562450 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562449 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562443 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562320 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562232 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562230 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7562226 ↗
• MalfunctionJun 1, 2018Material Separation; Torn Material; Material Split, Cut or Torn; Material Separation; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7560376 ↗
• MalfunctionMay 31, 2018Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7556916 ↗
• MalfunctionMay 31, 2018Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7556915 ↗
• MalfunctionMay 31, 2018Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7556914 ↗
• MalfunctionMay 31, 2018Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7556912 ↗
• MalfunctionMay 30, 2018Material Separation; Material Integrity Problem; Torn Material; Material Split, Cut or Torn; Material Separation; Material Integrity Problem; Torn Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE OUTER COATING ON THE FRONT AND SLEEVES OF THE GOWN APPEARS TO HAVE COME AWAY FROM THE BACKING MATERIAL, AS WELL AS THINNING AND TEARING OF THE OUTER LAYER. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7554418 ↗