Halyard 98433Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10680651984330), received between Jan 16, 2017 and May 29, 2020 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (26 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2020Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2020-00090 FOR THE SECOND EVENT. REFER TO 9611594-2020-00091 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS AN INCIDENT OF SUTURES BREAKING ON T-FASTENERS WHEN THE USER ATTEMPTED TO DILATE THE "TRACT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE USER STATED, "WE ENDED UP PLACING THE G-TUBE [GASTROSTOMY TUBE] IN THE PATIENT WITHOUT INCIDENT. THE PATIENT IS DOING FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102579 ↗
• MalfunctionMay 29, 2020Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2020-00089 FOR THE FIRST EVENT. REFER TO 9611594-2020-00091 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS AN INCIDENT OF SUTURES BREAKING ON T-FASTENERS WHEN THE USER ATTEMPTED TO DILATE THE "TRACT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE USER STATED, "WE ENDED UP PLACING THE G-TUBE [GASTROSTOMY TUBE] IN THE PATIENT WITHOUT INCIDENT. THE PATIENT IS DOING FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102573 ↗
• MalfunctionJan 8, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT AND INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2020-00004 FOR THE SECOND REPORT. IT WAS REPORTED THAT "ONE THREAD OF GASTROINTESTINAL ANCHOR SET SNAPPED A FEW HOURS LATER AFTER SURGERY...NOW, ADDITIONAL TREATMENT FOR SETTING ANCHORS HAS NOT BEEN PERFORMED YET. ADDITIONAL INFORMATION RECEIVED ON 18-DEC-2019 INDICATED THAT NO MEDICAL INTERVENTION WAS WARRANTED; "THIS MEDICAL CASE GOT A FOLLOW-UP EXAMINATION." PATIENT'S CURRENT STATUS WAS LISTED AS "THERE IS NO PROBLEM WITH HIS CONDITION." THE FIRST THREAD SNAPPED ON (B)(6) 2019, THE SAME DAY OF THE SURGERY. FOR NOW, REOPERATION IS NOT PLANNED AND THIS CASE GOT A FOLLOW-UP EXAMINATION. THERE IS NO MEDICAL INTERVENTION. HE HAS NOT DEVELOPED COMPLICATIONS AFTER THE SURGERY AND NUTRIENT FEEDING HAS BEEN PERFORMED WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9563428 ↗
• MalfunctionJan 8, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT AND INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2020-00003 FOR THE FIRST REPORT. IT WAS REPORTED THAT "A COUPLE OF DAYS LATER [AFTER SURGERY], THE SECOND THREAD [OF THE GASTROINTESTINAL ANCHOR SET] SNAPPED. NOW, ADDITIONAL TREATMENT FOR SETTING ANCHORS HAS NOT BEEN PERFORMED YET. ADDITIONAL INFORMATION RECEIVED 18-DEC-2019 INDICATED THAT NO MEDICAL INTERVENTION WAS WARRANTED; "THIS MEDICAL CASE GOT A FOLLOW-UP EXAMINATION." PATIENT'S CURRENT STATUS WAS LISTED AS "THERE IS NO PROBLEM WITH HIS CONDITION." THE SECOND ONE [THREAD] SNAPPED ON (B)(6) 2019. FOR NOW, REOPERATION IS NOT PLANNED AND THIS CASE GOT A FOLLOW-UP EXAMINATION. THERE IS NO MEDICAL INTERVENTION. HE HAS NOT DEVELOPED COMPLICATIONS AFTER THE SURGERY AND NUTRIENT FEEDING HAS BEEN PERFORMED WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9563427 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ANCHOR SUTURES RELEASED/LOOSENED WHILE DILATING THE STOMA. THE SURGEON HAD TO OPEN A NEW KIT TO COMPLETE THE PROCEDURE. THIS LENGTHENED THE TIME OF THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449772 ↗
• MalfunctionAug 26, 2019Break; Break

  IT WAS REPORTED THAT "DURING AN IPK [INTRODUCER KIT] PLACEMENT (RADIOLOGICAL), THE DILATOR, 'WHICH IS RADIOPAQUE ONLY ON DISTAL END' BROKE APART IN THE PATIENT WHILE DOING PROCEDURE. STATES THAT SINCE THE INNER PART OF THE DILATOR ISN'T RADIOPAQUE, THE PHYSICIAN, AFTER TUNNELING REMOVED THE DILATOR AND DISCOVERED THAT THE INNER PIECES OF DILATOR HAD BROKEN OFF AND WERE INSIDE OF THE PATIENT. PATIENT WAS TAKEN TO OR [OPERATING ROOM]TO HAVE BROKEN PIECES THAT WERE LEFT INSIDE REMOVED. SURGERY WAS UNEVENTFUL AND ALL PIECES WERE REMOVED WITHOUT COMPLICATIONS. NO INJURY TO PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8930866 ↗
• MalfunctionMar 26, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 9611594-2019-00058 FOR THE FIRST EVENT. REFER TO 9611594-2019-00059 FOR THE SECOND EVENT. REFER TO 9611594-2019-00061 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00062 FOR THE FIFTH EVENT. THE SUTURES ON THE T-FASTENERS BROKE DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453622 ↗
• MalfunctionMar 24, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 9611594-2019-00058 FOR THE FIRST EVENT. REFER TO 9611594-2019-00059 FOR THE SECOND EVENT. REFER TO 9611594-2019-00060 FOR THE THIRD EVENT. REFER TO 9611594-2019-00061 FOR THE FOURTH EVENT. THE SUTURES ON THE T-FASTENERS BROKE DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446729 ↗
• MalfunctionMar 24, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 9611594-2019-00058 FOR THE FIRST EVENT. REFER TO 9611594-2019-00060 FOR THE THIRD EVENT. REFER TO 9611594-2019-00061 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00062 FOR THE FIFTH EVENT. THE SUTURES ON THE T-FASTENERS BROKE DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446728 ↗
• MalfunctionMar 22, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 9611594-2019-00058 FOR THE FIRST EVENT. REFER TO 9611594-2019-00059 FOR THE SECOND EVENT. REFER TO 9611594-2019-00060 FOR THE THIRD EVENT. REFER TO 9611594-2019-00062 FOR THE FIFTH EVENT. THE SUTURES ON THE T-FASTENERS BROKE DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446502 ↗
• MalfunctionMar 22, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 9611594-2019-00059 FOR THE SECOND EVENT. REFER TO 9611594-2019-00060 FOR THE THIRD EVENT. REFER TO 9611594-2019-00061 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00062 FOR THE FIFTH EVENT. THE SUTURES ON THE T-FASTENERS BROKE DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446500 ↗
• InjuryMar 22, 2019Break; Break

  IT WAS REPORTED THAT THE ANCHOR SUTURES FOR THE GASTROPEXY BROKE TWO HOURS AFTER PLACEMENT. THE HOSPITAL ALLEGES THAT AS A RESULT OF THE BREAKS, THE PATIENT DEVELOPED PERITONITIS AND REQUIRED SURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED 20 MAR 2019, THE PATIENT'S SURGICAL INTERVENTION WAS SUCCESSFUL AND THE PATIENT IS "SAFE."

  Patient problems: Peritonitis

  MAUDE report 8446364 ↗
• MalfunctionMar 6, 2019Break; Break

  AN FDA USER FACILITY REPORT FORM # MW (B)(4) WAS RECEIVED ON 13-FEB-2019 THAT STATED: "DESCRIBE THE EVENT OR PROBLEM. CANCER OF NASOPHARYNX ON CHEMOTHERAPY CISPLATIN AND RADIATION THERAPY. PATIENT HAD A PEG TUBE PLACED IN ABDOMEN IN (B)(6). PATIENT ASKED TO BE SEEN TODAY IN RADIATION WITH COMPLAINT OF ABDOMINAL DRESSING VERY WET COVERING THE PEG TUBE. I HAD THE RN REMOVE THE DRESSING WITH THE INTENT TO REDO IT BUT WHEN THE RN REMOVED THE DRESSING THE G-TUBE WAS SITTING IN THE DRESSING COMPLETELY OUT OF THE PATIENT'S STOMACH AS THE TUBE HAD COME DISLODGED AT SOME POINT. PATIENT SLEEPS ON HIS ABDOMEN AT NIGHT. " AT ONE POINT THE PATIENT HAD 4 OF WHAT THE PHYSICIAN WHO PLACED THE 2 CALLED TACKS. THEY LOOK LIKE LITTLE BUTTONS, BUT THERE ARE ONLY 2 CURRENTLY, ONE ALMOST DETACHED AND THE SECOND ONE VERY SECURED TO THE ABDOMEN. THERE WERE NO OTHER NOTABLE TUBES THERE. PATIENT ALSO HAS SIGNIFICANT ERYTHEMA AROUND ONE OF THE AREAS. I AM UNCERTAIN HOW THE ABDOMEN IS GOING TO LOOK ONCE THAT IS REMOVED. PATIENT HAS NOT BEEN USING THE TUBE BUT PRIMARILY HAS BEEN FLUSHING IT. PLAN IS TO REINSERT THE FEEDING TUBE TOMORROW. THE NEXT DAY THE PATIENT REFUSED PLACEMENT OF THE G-TUBE TODAY AS SCHEDULE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396176 ↗
• MalfunctionMar 2, 2019Break; Break

  IT WAS REPORTED THAT A DOCTOR ATTEMPTED TO USE THE SUTURES OUT OF A KIT TO SECURE THE STOMACH. THREE OUT OF FOUR SUTURES SNAPPED/BROKE WITH VERY LITTLE TENSION. THE DOCTOR DID NOT WANT TO ATTEMPT TO USE THE REMAINING ONE THAT WAS LEFT IN THE KITS, SO ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384645 ↗
• InjuryDec 28, 2018Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2018-00237 FOR THE FIRST EVENT. IT WAS REPORTED THAT DURING A PROCEDURE AN ANCHOR BROKE AND ANOTHER SAFE-T-PEXY WAS USED TO REPLACE THE BROKEN ANCHOR. ADDITIONALLY, ANOTHER ANCHOR BROKE AND WAS REPLACED.

  Patient problems: Bowel Perforation

  MAUDE report 8202289 ↗
• InjuryDec 28, 2018Migration; Migration

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2018-00238 FOR THE SECOND EVENT FOR THE NOTED TWO BROKEN ANCHORS. IT WAS REPORTED THAT THE 18FR GASTROSTOMY TUBE WOULD NOT FIT INSIDE THE 22FR DILATOR PROVIDED IN THE KIT. THE DISTRIBUTOR BELIEVED THAT THE SURGEON FORCED THE TUBE THROUGH THE PEEL AWAY SHEATH, AND THIS RESULTED IN A GASTRIC AND SPLEEN PERFORATION IN THE PATIENT. AN EMERGENCY SPLENECTOMY WAS PERFORMED, THE PATIENT IS CURRENTLY IN INTENSIVE CARE. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2018, THE DILATOR WAS NOT TESTED PRIOR TO USE. THE INTRODUCTION OF THE LAST DILATOR WAS VERY DIFFICULT, THE PRACTITIONER HAD TO USE MORE FORCE THAN USUAL, AT WHICH POINT AN ANCHOR BROKE AND WAS REPLACED. THE DILATION CONTINUED AND THE PRACTITIONER WAS ABLE TO PLACE THE LAST INTRODUCER AND UNLOCKED THE PEEL AWAY SHEATH. THE SHEATH WAS UNABLE TO PASS THROUGH THE DILATOR TO THE PRACTITIONER PUSHED WITH HIS HAND AT THE TOP OF THE SHEATH. THIS ACTION PUNCTURED THE STOMACH AND DAMAGED THE SPLEEN OF THE PATIENT. DURING THIS TIME,

  Patient problems: Bowel Perforation

  MAUDE report 8202288 ↗
• MalfunctionFeb 7, 2018Break; Break

  IT WAS REPORTED THAT DURING THE DILATATION PART OF THE PROCEDURE, TWO T-FASTENERS FROM THE KIT BROKE. A NEW PACKAGE OF SUTURES WAS OPENED TO COMPLETE THE PROCEDURE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO HALYARD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248059 ↗
• MalfunctionJan 25, 2018Break; Break

  IT WAS REPORTED THE "T-FASTENERS BROKE IN USE." ADDITIONAL INFORMATION RECEIVED 10-JAN-2018 STATED THE PROCEDURE WAS COMPLETED WITH NEW T-FASTENERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7219253 ↗
• MalfunctionDec 28, 2017Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE AND 2 ANCHORS CAME OFF IN 2-DAYS AFTER PLACEMENT. AN ADDITIONAL PROCEDURE TO REPAIR AND SECURE THE STOMACH TO THE ABDOMINAL WALL WAS PERFORMED WITH A FUNADA-KIT UNDER LOCAL ANESTHESIA. THERE WAS NO REPORTED PATIENT INJURY. THE DOCTOR NOTED THAT THE INCISION WAS SMALL AND IT WAS DIFFICULT TO PEEL DILATOR OFF, "SO THERE MAY HAVE BEEN EXTRA FORCE APPLIED IN DILATION PROCESS." NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS AND THE OUTCOME OF THE PROCEDURE.

  Patient problems: Organ Dehiscence

  MAUDE report 7151191 ↗
• MalfunctionDec 27, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY TWO ANCHORS BROKE AND THE BOTH ANCHORS DROPPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7147749 ↗
• MalfunctionNov 30, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2017-00152 FOR THE FIRST PATIENT. IT WAS REPORTED THAT A PHYSICIAN HAD THE SUTURES PULLED UP AND LOCKED IN PLACED WHEN FOUR OF THE SUTURES BROKE. THE FIRST KIT WAS REPLACED BY A SECOND KIT. AFTER THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT, THE NURSE REPORTED THAT ONE SUTURE BROKE FROM THE SECOND KIT. IT WAS NOTED THAT THE SUTURES BROKE WHILE THE PHYSICIAN WAS CLOSING THE INCISION, AND THE STOMACH HAD TO BE RE-INSUFFLATED. THE PHYSICIAN STATED THAT THE PROCEDURE WAS PROLONGED AS A RESULT. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072388 ↗
• MalfunctionNov 30, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2017-00153 FOR THE SECOND PATIENT. IT WAS REPORTED THAT A PHYSICIAN HAD THE SUTURES PULLED UP AND LOCKED IN PLACED WHEN FOUR OF THE SUTURES BROKE. THE FIRST KIT WAS REPLACED BY A SECOND KIT. AFTER THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT, THE NURSE REPORTED THAT ONE SUTURE BROKE FROM THE SECOND KIT. IT WAS NOTED THAT THE SUTURES BROKE WHILE THE PHYSICIAN WAS CLOSING THE INCISION, AND THE STOMACH HAD TO BE RE-INSUFFLATED. THE PHYSICIAN STATED THAT THE PROCEDURE WAS PROLONGED AS A RESULT. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072385 ↗
• InjuryOct 19, 2017Break; Break

  IT WAS REPORTED THAT THE T-FASTENER BROKE. ADDITIONAL INFORMATION WAS RECEIVED ON 10-OCT-2017 THAT STATES, THERE WAS A TOTAL OF FOUR T-FASTENERS THAT BROKE. THE FIRST T-FASTENER BROKE IN THE OPERATING ROOM WHILE THE PATIENT WAS BEING TRANSFERRED FROM OPERATING ROOM BED TO STRETCHER. THE SECOND T-FASTENER WAS FOUND DISLODGED ON POD #1 (THE FOLLOWING MORNING BY NURSING). THE THIRD T-FASTENER WAS OFF THE FOLLOWING MORNING POD #2. THE FOURTH T-FASTENER WAS NO LONGER IN PLACE WHILE THE PATIENT WAS BEING BROUGHT BACK TO THE OPERATING ROOM (MORNING OF POD #3). THE PATIENT HAD SIGNIFICANT ABDOMINAL WALL SOFT TISSUE INFECTION THAT REQUIRED IV ANTIBIOTICS AND DEBRIDEMENT. ALSO, THE PATIENT UNDERWENT A SECOND OPERATION TO REPLACE HIS EXISTING J TUBE, AND HIS ABDOMINAL WOUND REQUIRED PACKING WHICH WAS UNCOMFORTABLE FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6963355 ↗
• MalfunctionJun 29, 2017Break; Break

  IT WAS REPORTED THAT TWO SUTURES BROKE THREE DAYS AFTER PLACEMENT AND A SUTURE BROKE ON THE FOLLOWING DAY. THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT IS A (B)(6) MALE SUFFERING FROM CONGENITAL DEVELOPMENTAL DISORDERS WITH AN ESTIMATED HEIGHT OF 120CM. THE PATIENT HAS STRONG MUSCLE CONTRACTIONS AND VISCERAL ANOMALIES. DURING THE OPERATION, NEEDLES WERE OBLIQUELY PUNCTURED DUE TO THE VISCERAL ANOMALIES AND SUTURES WERE HELD WITH FORCEPS NEAR BODY SURFACE UNTIL THE FIXATION COULD BE CONFIRMED VIA FLUOROSCOPY. PER ADDITIONAL INFORMATION RECEIVED WHEN THE REP VISITED THE HOSPITAL, A MIC-KEY GJ TUBE WAS PLACED. THERE WAS NO ADDITIONAL FIXATION PERFORMED. THE STOMACH IS CURRENTLY HELD ONLY IN PLACE WITH THE TUBE. THE PATIENT WILL STAY IN THE HOSPITAL A FEW DAYS LONGER THAN EXPECTED FOR OBSERVATION.

  Patient problems: No Code Available

  MAUDE report 6676392 ↗
• MalfunctionFeb 2, 2017Break; Break

  DURING A MAUDE DATABASE REVIEW, MAUDE REPORT (B)(4) WAS IDENTIFIED AND STATED, THE PATIENT WAS UNDERGOING A GASTROSTOMY TUBE PLACEMENT, AND WHILE ANCHORING SUTURES INTO THE PATIENT'S GASTRIC LUMEN, ONE OF THE THREE SUTURES PLACED IMMEDIATELY BROKE. A NEW SUTURE WAS PLACED AND THE PROCEDURE CONTINUED WITH NO IMMEDIATE COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298596 ↗