GYNECARE INTERCEED 4350XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 10705031147843), received between Nov 21, 2017 and Sep 28, 2026 — classified as 2 deaths, 128 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Delivered as Unsterile Product

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and an absorbable adhesion barrier was used. It was reported that the device package seal is open when unpacking and counting. One end of the package is not sealed. Changed another one to complete the surgery. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917030 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Fever

  MAUDE report 50887876 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50887280 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50886895 ↗
• MalfunctionJun 22, 2026Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MILES RESECTION PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTATIC BARRIER WAS USED. DURING A LAPAROSCOPIC MILES FOR COLON CANCER, IT WAS FOUND THAT THE PRODUCT WAS LARGE SIZE THOUGH IT SHOULD BE REGULAR SIZE WHEN THE PACKAGE WAS OPENED. THE PRODUCT WAS USED ON THE FASCIA. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579788 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND AN ABSORBABLE ADHESIVE BARRIER WAS USED. AN ILEUS OCCURRED. THE ILEUS WAS RELEASED BY AN OPEN SURGERY REOPERATION. AFTER THE REOPERATION, THE PATIENT¿S CONDITION IS STABLE. SHE HAS FINALLY STARTED EATING AGAIN. ACCORDING TO THE DOCTOR¿S OPINION THROUGH CT, THE AREA WHERE ABSORBABLE ADHESIVE BARRIER WAS APPLIED WAS NOT ADHERED. HOWEVER, THERE IS A POSSIBILITY THAT ADHESIONS OCCURRED AROUND THE AREAS WHERE THE SHEET WAS NOT APPLIED. THE DOCTOR ALSO COMMENTED THAT FLUID MAY HAVE ACCUMULATED IN THE GAPS, CAUSING INFLAMMATION OR AN ABSCESS, WHICH MAY HAVE LED TO THE ILEUS. THE DOCTOR ALSO BELIEVES THAT THIS EVENT WAS CAUSED BY ABSORBABLE ADHESIVE BARRIER AND COMMENTED THAT IT SHOULD BE AVOIDED IN SURGERIES WHERE EVEN SLIGHT INFLAMMATION MAY OCCUR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Adhesion(s); Fluid Discharge; Inflammation; Obstruction/Occlusion

  MAUDE report 24326435 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. IT WAS FOUND THAT THE PERFORATIONS IN THE STERILE PACKAGE WAS OPENED. THE PRODUCT WAS NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810508 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ABOUT 10 YEARS AGO AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE PATIENT HAD DEVELOPED AN ABSCESS AFTER USING AN ADHESION-PREVENTATIVE BARRIER. SINCE THIS WAS ABOUT 10 YEARS AGO, DOCTORS HAVE DIFFERENT PERCEPTIONS ON WHETHER THE PRODUCT USED WAS INTERCEED OR SEPRAFILM. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: Abscess

  MAUDE report 23340756 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT WAS A CAESAREAN SECTION (C-SECTION) ON AN UNSPECIFIED DATE AND AN ABSORBABLE ADHESION BARRIER WAS APPLIED. THE MEDICAL CENTER HAS NOT USED ANY ADHESION-PREVENTATIVE BARRIERS DURING A C-SECTION DUE TO PAST ABSCESSES, BUT THE OB-GYN DEPARTMENT AT THIS FACILITY USES ABSORBABLE ADHESION BARRIERS IN ALL CASES. THIS TIME, THE BARRIER WAS APPLIED AS USUAL, BUT THE PATIENT CONTINUED TO HAVE A FEVER FOR ABOUT A WEEK AFTER THE SURGERY, AND AN INFLAMMATORY REACTION WAS ALSO OBSERVED IN THE ABDOMINAL CAVITY, CAUSING CONSIDERABLE DIFFICULTY IN MANAGING THE SITUATION. THE PATIENT IS FEMALE. AS MENTIONED ABOVE, THE CUSTOMER IS AWARE OF THE ABSCESS THAT DEVELOPED, AND WONDERING IF THE ABSORBABLE ADHESION BARRIER MAY BE THE CAUSE. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Fever; Inflammation

  MAUDE report 23339702 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. AN INTESTINAL OBSTRUCTION OCCURRED AFTER SURGERY WHEN THE ABSORBABLE ADHESION BARRIER WAS APPLIED JUST BELOW THE UMBILICAL WOUND. REOPERATION WAS PERFORMED, THE ABSORBABLE ADHESION BARRIER WAS STUCK TO THE SMALL INTESTINE AND CAUSED REDNESS AND INFLAMMATION. THE SMALL INTESTINE IN THAT AREA HAD BECOME FOLDED AND CAUSED AN INTESTINAL OBSTRUCTION. THE INFLAMED SMALL INTESTINE WAS REMOVED AND RECONSTRUCTED. IT WAS CONFIRMED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AT THIS TIME. THE DOCTOR IN CHARGE HAS ASKED WHETHER THERE HAVE BEEN ANY REPORTS OF SIMILAR HEALTH PROBLEMS. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Obstruction/Occlusion

  MAUDE report 23084812 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UTERINE AND RECTAL PROLAPSE PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS APPLIED TO THE PELVIC FLOOR. AN ABSCESS DEVELOPED AT THE APPLICATION PART AFTER SURGERY. THE ABSCESS WAS DISCOVERED DURING HOSPITALIZATION. DRAINAGE WAS PERFORMED ON THE VAGINA AND ADDITIONAL ANTIBIOTICS WERE ADMINISTERED. THE PRODUCT WAS USED ON THE PELVIC FLOOR. CURRENTLY THE PATIENT IS HOSPITALIZED AND UNDER OBSERVATION. THE DOCTOR COMMENTED THAT PELVIC FLOOR PROCEDURES SUCH AS ABDOMINOPERINEAL RESECTION CAN CAUSE INFLAMMATION OF PELVIC DEAD SPACE AND INFECTION IN THE SHORT TERM AFTER SURGERY, BUT IF AN ABSORBABLE ADHESION BARRIER IS NOT APPLIED, THERE IS A RISK OF ILEUS IN THE LONG TERM. IT IS DIFFICULT TO DECIDE WHETHER TO APPLY AN ANTIADHESIVE MATERIAL. THE ADHESION BARRIER CAN BE REAPPLIED BUT CONSIDERING THE POSSIBILITY OF IT SLIPPING OFF AFTER APPLICATION AND CAUSING INFECTION, SEPRAGILM IS ALSO AN OPTION. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess

  MAUDE report 23037879 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2025 AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE ADHESION BARRIER WAS APPLIED TO COMPLETE THE CASE. POST-OP. AN ABSCESS WAS FOUND ON THE SUTURING SITE OF THE MYOMETRIUM A FEW DAYS LATER AFTER SURGERY. REOPERATION AND DRAINAGE WERE PERFORMED. THE PATIENT WAS STABLE AFTER THE REOPERATION. THE DOCTOR COMMENTED THAT THE PATIENT HAD RUPTURED WATER AND WAS AT RISK OF INTRAUTERINE INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 22965361 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT HEMICOLECTOMY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. AN INFECTION OCCURRED AT THE LOCATION OF THE ABSORBABLE ADHESION BARRIER ON A CT SCAN. THE PRODUCT WAS USED ON THE DIRECTLY BELOW THE UMBILICAL MINILAPAROTOMY. THE PATIENT HAS A LOT OF VISCERAL FAT. CT SCAN WAS PERFORMED BECAUSE A BLOOD TEST TAKEN THREE DAYS AFTER SURGERY SHOWED A HIGH CRP22 LEVEL. THE PATIENT'S ONLY SYMPTOMS ARE MILD TENDERNESS JUST BELOW THE SCROTUM. THERE IS NO FEVER. THE PATIENT IS BEING FOLLOWED UP. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22913143 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE ADHESION BARRIER WAS ATTACHED JUST UNDER THE ABDOMINAL WALL. ON POST-OP DAY 7, THE PATIENT HAD A FEVER. AN ABSCESS JUST UNDER THE ABDOMINAL WALL WAS CONFIRMED BY CT. DRAINAGE OF THE ABSCESS WAS PERFORMED. NO PARTICULAR PROBLEMS OCCURRED AFTER DRAINAGE. THE SURGEON OPINED IT IS POSSIBLE THAT THE ADHESION BARRIER WAS THE CAUSE BECAUSE THERE WAS AN ABSCESS JUST UNDER THE ABDOMINAL WALL WHERE THE ADHESION BARRIER WAS ATTACHED. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Fever

  MAUDE report 21935255 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC COLECTOMY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED UNDER THE INCISION. AFTER THAT RE-OPERATION WAS PERFORMED DUE TO OTHER FACTORS. THE AREA WHERE THE ADHESION BARRIER WAS APPLIED WAS TANGLED WITH FAT, FORMING A MASS LIKE AN ABSCESS WHEN THE LAPAROTOMY WAS PERFORMED. THERE WAS ALSO ADHESION IN THE SAME AREA. IT TOOK A LONG TIME TO REMOVE THE ADHESION DURING THE RE-OPERATION. IT WAS FOUND THAT THE ADHESION BARRIER HAD ADHERED TO THE OMENTUM, AND WAS REMOVED DURING THE REOPERATION. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Adhesion(s)

  MAUDE report 21935230 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEPATECTOMY ON AN UNKNOWN DATE AN ABSORBABLE ADHESION BARRIER WAS USED. AN INTRA-ABDOMINAL ABSCESS AND INFECTION OCCURRED. THE INFECTION OCCURRED OVER A WIDE AREA WITH EXTENSION TO THE SURROUNDING AREA OF THE STOMACH FROM THE LIVER OF THE AFFECTED AREA. THE PATIENT HAD A FEVER 2 WEEKS AFTER SURGERY, SO WHEN EXAMINED, AN ABSCESS WAS DISCOVERED. AFTER THAT, DRAINAGE WAS PERFORMED IN TWO SESSIONS, BUT IT WAS DIFFICULT, AND DRAINAGE WAS FINALLY COMPLETED WITH THE 3RD TIME IN THE 3RD WEEK. EVEN 3 WEEKS AFTER THE SURGERY, THE PATIENT HAD PLURAL EFFUSION, AND THE DRAIN COULD NOT BE REMOVED STILL NOW. IT IS UNKNOWN WHETHER THE ABSORBABLE ADHESION BARRIER WAS THE CAUSE, BUT THE DOCTOR IS CONCERNED THAT IT MAY BE THE CAUSE. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Fever; Pleural Effusion; Unspecified Infection

  MAUDE report 21656678 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGIC SURGERY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE C REACTIVE PROTEIN VALUES INCREASED BY ABOUT 10 WHEN THE ABSORBABLE ADHESION BARRIER WAS USED. NO SUCH EXPERIENCE WITH OTHER ANTI-ADHESIVE AGENTS (SEPRA, ADSPRAY). THE C REACTIVE PROTEIN LEVEL SEEMS TO BE ELEVATED WHEN THE PATIENT HAS SEVERE ADHESIONS, AND INFECTION ALSO OCCURRED WHEN USING THE ABSORBABLE ADHESION BARRIER. IT IS NOT KNOWN IF THE ELEVATED C REACTIVE PROTEIN AND INFECTION WERE CAUSED BY THE ABSORBABLE ADHESION BARRIER, HOWEVER, THE PHYSICIAN IS UNDER THE IMPRESSION THAT IT WAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 21124852 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGIC SURGERY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE C REACTIVE PROTEIN VALUES INCREASED BY ABOUT 10 WHEN THE ABSORBABLE ADHESION BARRIER WAS USED. NO SUCH EXPERIENCE WITH OTHER ANTI-ADHESIVE AGENTS (SEPRA, ADSPRAY). THE C REACTIVE PROTEIN LEVEL SEEMS TO BE ELEVATED WHEN THE PATIENT HAS SEVERE ADHESIONS, AND INFECTION ALSO OCCURRED WHEN USING THE ABSORBABLE ADHESION BARRIER. IT IS NOT KNOWN IF THE ELEVATED C REACTIVE PROTEIN AND INFECTION WERE CAUSED BY THE ABSORBABLE ADHESION BARRIER, HOWEVER, THE PHYSICIAN IS UNDER THE IMPRESSION THAT IT WAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 21124490 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGIC SURGERY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE C REACTIVE PROTEIN VALUES INCREASED BY ABOUT 10 WHEN THE ABSORBABLE ADHESION BARRIER WAS USED. NO SUCH EXPERIENCE WITH OTHER ANTI-ADHESIVE AGENTS (SEPRA, ADSPRAY). THE C REACTIVE PROTEIN LEVEL SEEMS TO BE ELEVATED WHEN THE PATIENT HAS SEVERE ADHESIONS, AND INFECTION ALSO OCCURRED WHEN USING THE ABSORBABLE ADHESION BARRIER. IT IS NOT KNOWN IF THE ELEVATED C REACTIVE PROTEIN AND INFECTION WERE CAUSED BY THE ABSORBABLE ADHESION BARRIER, HOWEVER, THE PHYSICIAN IS UNDER THE IMPRESSION THAT IT WAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 21124485 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE IN 2024 AND AN ABSORBABLE ADHESION BARRIER WAS USED. AFTERWARDS, PATIENT PRESENTED WITH REDNESS AROUND THE INCISIONS. NOW, 2 MONTHS POD, PATIENT HAD REDNESS ACROSS THE ABDOMEN, NOT LIMITED TO AROUND THE LAP INCISION. SURGEON GAVE PATIENT STEROIDS. PATIENT FOLLOWED UP WITH A DERMATOLOGIST THAT CONCLUDED THAT IT WAS AN INFECTION. UNABLE TO TRACE LOT NUMBER OF ITEMS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 20902138 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED OB-GYN PROCEDURE ON (B)(6) 2024 AND AN ABSORBABLE ADHESION BARRIER WAS USED ON THE PELVIC FLOOR. THE OPERATION TIME WAS NO EXTENSION. UNKNOWN INFECTION OCCURRED. THE DOCTOR THOUGHT THAT IT WAS NOT DUE TO THE ABSORBABLE ADHESION BARRIER. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED ON (B)(6) 2024 FROM THE HOSPITAL AND RECOVERED FROM SURGERY. THE PATIENT IS ATTENDING A DOCTOR. THE PATIENT HAD ABDOMINAL PAIN AND FEVER POSSIBLY DUE TO ADHESIONS AFTER SURGERY. DILATION OF THE INTESTINAL TRACT WAS FOUND WHEN THE CT WAS CHECKED. RE OPERATION WAS PERFORMED ON (B)(6) 2024 DUE TO POSSIBLE INTESTINAL DAMAGE. THE ABDOMINAL CAVITY HAD ADHESIONS ON THE PELVIC FLOOR, AND THE PERITONEUM WAS CLOSED AND THE RINGWORM WAS CONFIRMED. IT WAS WASHED AFTER DISSECTION WAS PERFORMED. ABSORBABLE ADHESION BARRIER PRODUCT WAS APPLIED TO PELVIC FLOOR BEFORE PERITONEAL SUTURE AFTER REMOVED GELPOINT V-PATH DURING SURGERY TO PREVENT ADHESIONS AFTER SURGERY. THE DOCTOR RECOGNIZED THAT THERE WAS AN INFECTIOUS CAUSE DUE TO TRANSVAGINAL USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abdominal Pain; Adhesion(s); Fever; Unspecified Infection

  MAUDE report 20880837 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC-ASSISTED COLECTOMY ON (B)(6) 2024 AND AN ABSORBABLE ADHESION BARRIER WAS USED. AFTER DOUBLE STAPLING TECHNIQUE ANASTOMOSIS, THE ABSORBABLE ADHESION BARRIER WAS USED ON THE MEDIAN INCISION WOUND DIRECTLY UNDER THE WOUND. AFTER THE SURGERY, AN INTRA-ABDOMINAL TUMOR FORMED. THREE DAYS AFTER SURGERY, THE PATIENT COMPLAINED A FEVER AND ABDOMINAL PAIN, SO A DETAILED EXAMINATION WAS UNDERTAKEN. CRP VALUE WAS 6.7. ANTIBIOTIC TREATMENT WAS STARTED TO THE STOMACH, AND FEVER DISAPPEARED THE NEXT DAY, BUT ANTIBIOTICS WERE CONTINUED. ANASTOMOTIC INSUFFICIENCY WAS NOT FOUND. DURING WOUND CLOSURE AT OPERATION, ABSORBABLE ADHESION BARRIER WAS ATTACHED JUST BELOW THE UMBILICAL REGION AFTER CONFIRMING THERE WAS NO INTRA-ABDOMINAL BLEEDING. AFTER THAT, THE WOUND WAS CLOSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abdominal Pain; Abscess; Fever; Solid Tumor

  MAUDE report 20707234 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ROBOT-ASSISTED SURGERY ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE POSTOPERATIVE COURSE OF THE PATIENT WAS UNEVENTFUL, BUT THE INFECTION OCCURRED AFTER DISCHARGE FROM THE HOSPITAL. THE ASSOCIATION WITH PRODUCT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 20707173 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. DURING AN UNKNOWN SURGERY, THE PATIENT WHO USED THE ABSORBABLE ADHESION BARRIER BEFORE HAD INFLAMMATION (INFECTION?), ALTHOUGH IT IS NOT SURE IF THIS PRODUCT WAS THE REASON OR NOT. IT WAS USED ON DIGESTIVE ORGAN. A PATIENT IS HOSPITALIZED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20632373 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SINGLE SECTION LAP-APPENDECTOMY ON (B)(6) 2024 AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE CENTRAL CENTER WAS LIGATED WITH TWO ENDOLOOPS. AFTER DISSECTING AND EXCISION WITH SCISSORS. THE WOUND WAS THEN CLOSED WITH AN ABSORBABLE ADHESION BARRIER APPLIED. INFECTION OCCURRED POSTOPERATIVELY. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 20295656 ↗