Lynx™ Blue System M0068503010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729961932), received between Jan 6, 2020 and Dec 17, 2025 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN LYNX BLUE SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION TO SURROUNDING TISSUE, REPEATED INFECTIONS, RECURRENT STRESS URINARY INCONTINENCE, PELVIC PAIN, BACK PAIN, AND DYSURIA. THE PATIENT SUBSEQUENTLY THE PATIENT UNDERWENT A CYSTOSCOPY AND PARTIAL MESH REVISION ON (B)(6) 2023. THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTED DEVICE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO ADDITIONAL SURGERY, AND MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS, SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN AND SUFFERING, MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement; Dysuria; Erosion; Insufficient Information; Pain; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 23829965 ↗
• InjuryDec 8, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TROCAR WAS ACCIDENTALLY PASSED THROUGH THE BLADDER. WHEN THE TROCAR WAS REMOVED, IT CAUSED ADDITIONAL BLADDER TEARING. THE PROCEDURE WAS COMPLETED USING ANOTHER LYNX SLING DEVICE. AS A RESULT OF THIS INCIDENT, THE PATIENT EXPERIENCED COMPLICATIONS SUCH AS PERFORATION, HEMATOMA, AND BLEEDING, REQUIRING MEDICAL AND SURGICAL INTERVENTIONS, INCLUDING CATHETER AND ONGOING MONITORING FOR HEALING.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 23752158 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE LYNX BLUE SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS. THESE INCLUDE URINARY RETENTION REQUIRING CATHETERIZATION, MESH EXTRUSION, AND SCAR DEVELOPMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT MESH REVISION SURGERY ON (B)(6) 2023. A PARTIAL MESH REMOVAL WAS PERFORMED ON (B)(6) 2023, FOLLOWED BY ANOTHER MESH REMOVAL SURGERY ON (B)(6) 2023. THE PATIENT ALSO CLAIMED TO HAVE SUFFERED SEVERE PAIN, UNNECESSARY EXPENSES, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTATION. ADDITIONALLY, SHE CLAIMS THAT SHE MAY NEED TO UNDERGO FURTHER SURGERY AND MAY, IN THE FUTURE, SUFFER DAMAGES SUCH AS SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement; Erosion; Insufficient Information; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Retention

  MAUDE report 22810240 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MANUFACTURER REPORT 2124215-2025-54043 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD BOTH A LYNX BLUE SYSTEM AND UPSYLON Y-MESH SYSTEM DEVICES IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS. THESE INCLUDE SMALL BOWEL OBSTRUCTION, INTERNAL HERNIA, ADHESIONS, SCARRING, PAIN INCLUDING DYSPAREUNIA, AND A LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS TO HAVE SUFFERED, OR MAY SUFFER IN THE FUTURE DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Adhesion(s); Dyspareunia; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 22747093 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LYNX BLUE SYSTEM IMPLANTED DURING A PROCEDURE FOR THE TREATMENT OF CYSTOCELE, VAGINAL VAULT PROLAPSE, URGE AND STRESS INCONTINENCE, URINARY INCONTINENCE DUE TO URETHRAL SPHINCTER INCOMPETENCE, PARAVAGINAL DEFECT AND OBSTRUCTED VOIDING PATTERN. THE IMPLANT PROCEDURE WAS PERFORMED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT DEVELOPED RECURRENT URINARY TRACT INFECTIONS AND VOIDING DYSFUNCTION. ON (B)(6) 2025, A SLING LYSIS AND CYSTOURETHROSCOPY WERE PERFORMED. DURING THE PROCEDURE, A MIDLINE VAGINAL INCISION WAS MADE AT THE LEVEL OF THE MID-URETHRA, WHERE THE MESH WAS IDENTIFIED AND CAREFULLY DISSECTED FROM SURROUNDING TISSUE USING BLUNT AND SHARP DISSECTION. THE SLING WAS RELEASED IN THE MIDLINE. CYSTOSCOPY REVEALED NO MESH OR FOREIGN MATERIAL IN THE BLADDER, AND THE BLADDER UROTHELIUM APPEARED NORMAL. THE VAGINAL EPITHELIUM WAS CLOSED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 22611991 ↗
• InjuryFeb 18, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, DURING A PROCEDURE, A LYNX DEVICE WAS USED. DUE TO THE CHALLENGING ANATOMY, THE TROCAR INADVERTENTLY PUNCTURED THE BLADDER, CAUSING THE PROCEDURE TO BE HALTED AND RESCHEDULED TO ENSURE PATIENT SAFETY AND ALLOW FOR PROPER COMPLICATION MANAGEMENT. THE PHYSICIAN WAS PLANNING TO COMPLETE THE PROCEDURE ONCE THE PATIENT HEALS. CURRENTLY, THE PATIENT STILL PRESENTS THE STRESS URINARY INCONTINENCE SYMPTOMS.

  Patient problems: Internal Organ Perforation; Urinary Incontinence

  MAUDE report 21395466 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS USED DURING A RETROPUBIC MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2018, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. ON (B)(6) 2019, THE PATIENT WAS DIAGNOSED WITH SLING MESH EXPOSURE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH AFTER, THE MESH WAS VISUALIZED, IT WAS GRASPED, AND THE EPITHELIUM DISSECTED AWAY FROM THE ELEMENTS OF THE PUBOVESICOCERVICAL FASCIAL BILATERALLY. THE SLING WAS THEN TRIMMED, AND IT WAS CONFIRMED THAT THERE WERE NO FURTHER PATIENT COMPLICATIONS. ON (B)(6) 2023, THE PATIENT PRESENTED RECURRING URINARY INCONTINENCE. A SURGICAL PROCEDURE TO IMPLANT A NEW SLING DEVICE WAS PLANNED; HOWEVER, WHEN CYSTOURETHROSCOPY WAS PERFORMED IT WAS NOTICED THAT A REMNANT PIECE OF THE ORIGINAL MESH WAS EXTRUDING INTO THE URETHRA. THE NEW IMPLANT WAS THEN ABORTED, AND THE PREVIOUS SLING WAS ABLE TO BE FULLY REMOVED WITH NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 19041142 ↗
• InjurySep 19, 2023Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING CYSTOSCOPY AND NATIVE TISSUE CYSTOCELE REPAIR, TRANSVAGINAL TAPE, AND SLING PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS INCONTINENCE AND CYSTOCELE. ON (B)(6) 2021, THE PATIENT UNDERWENT A SLING EXCISION AND CYSTOSCOPY PROCEDURE TO ADDRESS VARIOUS URINARY ISSUES. THESE INCLUDED URINARY HESITANCY, OVERACTIVE BLADDER, DYSPAREUNIA, AND EVIDENCE OF SLING MIGRATION ON MAGNETIC RESONANCE IMAGING (MRI). BEFORE THE PROCEDURE, THE VAGINAL MUCOSA WAS NOTED TO BE ATROPHIC, AND THERE WAS SCARRING AT THE BLADDER NECK. HOWEVER, THE CERVIX APPEARED NORMAL. DURING A RECTAL EXAM, NO MASSES WERE DETECTED, BUT A SMALL DISTAL RECTOCELE WAS FOUND WITH UPWARD RECTAL PRESSURE. THE SLING WAS THE ONLY MESH PALPABLE IN THE ANTERIOR/POSTERIOR COMPARTMENTS; HOWEVER, NO MESH EXPOSURE WAS IDENTIFIED. DURING THE PROCEDURE, THE MESH WAS NOTED TO BE INDENTING THE SUB-URETHRAL TISSUE. THE SLING WAS EXCISED UNTIL NO VISIBLE OR PALPABLE MESH COULD BE NOTED. A CYSTOURETHROSCOPY WAS PERFORMED, AND IT SHOWED NORMAL BILATERALLY EFFLUXING URETERS, A NORMAL URETHRA, AND NORMAL B

  Patient problems: Dyspareunia; Insufficient Information; Micturition Urgency; Prolapse; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17775393 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING A ROUTINE FOLLOW-UP A WEEK AFTER SURGERY, THE PATIENT DEVELOPED PAIN THAT GRADUALLY GOT WORSE. A TRIGGER POINT BLOCK WAS DONE ON (B)(6) 2023.. THE PATIENT COULD WALK WITHOUT PAIN, BUT IF SHE PUSHES ON HER LEFT INCISION, IT IS STILL VERY PAINFUL. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE.

  Patient problems: Pain

  MAUDE report 17584679 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS IMPLANTED DURING A LYNX RETROPUBIC SLING PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF STRESS INCONTINENCE. AFTER THE DEVICE WAS IMPLANTED, THE PATIENT WAS SUSPECTED TO HAVE DEVELOPED AN ALLERGIC REACTION TO THE MESH. SHE EXPERIENCED A SEVERE RASH AND ITCHING AROUND THE TWO ENTRY POINTS OF THE LYNX TROCARS. SUBSEQUENTLY, THE MESH WAS SUCCESSFULLY EXPLANTED ON (B)(6) 2023. THE PATIENT IS DOING MUCH BETTER AFTER THE EXPLANTATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16292509 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT CLAIMED TO HAVE SUFFERED THE FOLLOWING INJURIES AS A RESULT OF THE IMPLANTATION: CONSTANT PAIN, PELVIC PAIN, BACK PAIN, FAILED SLING, BLOOD INFECTIONS, URINARY TRACT INFECTIONS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED ECONOMIC DAMAGES SUCH AS MEDICAL BILLS AS WELL AS NON-ECONOMIC DAMAGES INCLUDING BUT NOT LIMITED TO PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, ANXIETY, DEPRESSION, PHYSICAL IMPAIRMENT, PERMANENT PHYSICAL INJURY, AND MORE.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Abscess; Anxiety; Bacterial Infection; Chills; Depression; Ecchymosis; Erosion; Fatigue; Hematoma; Hematuria; Hemorrhage/Blood Loss/Bleeding; Pain; Prolapse; Purulent Discharge; Unspecified Infection; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 15541125 ↗
• MalfunctionAug 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A LYNX BLUE SYSTEM WAS OPENED AND THE "END FELL OFF OF IT." THUS, IT WAS NOT IMPLANTED IN THE PATIENT. THE EVENT IS UNCLEAR. THE EVENT DESCRIPTION MAY SUGGEST THAT THE ASSOCIATION LOOP DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LYNX SYSTEM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15309459 ↗
• MalfunctionFeb 24, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS USED DURING MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2021 TO TREAT STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE SUCCESSFULLY AND THUS, THE SLING WAS NOT IMPLANTED INTO THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD AN UNUSUAL ANATOMY AND THE PHYSICIAN STRUGGLED TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN ADVANTAGE FIT SYSTEM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376709 ↗
• MalfunctionNov 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM DEVICE WAS USED DURING A SLING PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, PART OF THE PLASTIC SLEEVE DETACHED DURING THE PROCEDURE.THE DETACHED PIECE DID NOT FALL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LYNX BLUE SYSTEM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10815519 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SLING WAS IMPLANTED DURING A CYSTOCELE AND RECTOCELE REPAIR, AND HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2020 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. ACCORDING TO THE PATIENT, IMMEDIATELY AFTER THE PROCEDURE, SOMETHING WAS NOT RIGHT AT HER LEFT PUBIC BONE. THE PATIENT HAD SUFFERED PAIN FOR A MONTH WITH A LEVEL OF 9 EVERY TIME SHE WOULD COUGH OR SNEEZE, BUT THAT HAS GRADUALLY SUBSIDED. HOWEVER, SHE STILL EXPERIENCES PAIN. AT THE SIXTH WEEK FOLLOW-UP, IT WAS DISCOVERED THAT THE MESH ERODED INTO THE VAGINA. SINCE THEN, THE PATIENT HAS BEEN GOING BACK TO THE DOCTORS EVERY SIX TO EIGHT WEEKS BUT IS STILL UNABLE TO HAVE INTERCOURSE. IN ADDITION TO ESTROGEN CREAM AND PILLS, THE PATIENT HAS DONE THREE LASER TREATMENTS AND STILL HAS PAIN ON THE RIGHT SIDE OF THE VAGINA. REPORTEDLY, SHE CAN FEEL THE SLING AT THE POINT OF PAIN AT THE TOP OF THE VAGINA AND INTERCOURSE FEELS LIKE A BOTTLE OF BRUSH. FURTHERMORE, THE PATIENT REPORTS OF EXPERIENCING BLEEDING. SUBSEQUENTLY, THERE IS A POSSIBILITY OF UNDERGOING ANOTHER SURGERY TO TRIM OR REMOVE THE MESH.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 10141413 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS PERTAINS TO THE SECOND OF TWO DEVICES IMPLANTED INTO THE PATIENT DURING TWO DIFFERENT PROCEDURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX BLUE SIS SYSTEM WAS IMPLANTED DURING A SINGLE INCISION SLING PROCEDURE PERFORMED ON (B)(6) 2019 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT EXPERIENCED MORE BLADDER LEAKAGE THAN SHE HAD BEFORE. ON (B)(6) 2019, A MESH REMOVAL AND PLACEMENT OF RETROPUBIC SLING WAS PERFORMED BY REMOVING THE SOLYX SLING FROM THE ORIGINAL SURGERY AND WAS REPLACED WITH A LYNX SLING. THERE WERE NO PATIENT COMPLICATIONS NOTED AFTER THE REVISION. ON (B)(6) 2019, THE PATIENT RETURNED TO THE PHYSICIAN BECAUSE THE PATIENT DEVELOPED INCOMPLETE BLADDER EMPTYING WITH STRAINING TO VOID WHICH REQUIRED A SELF-CATHETERIZATION. ON THE SAME DAY, THE PHYSICIAN INCISED THE LYNX SLING. DURING THE PATIENT'S FOLLOW-UP VISIT AFTER THE SLING INCISION, THE PATIENT IS REPORTEDLY STILL EXPERIENCING LEAKING MORE THAN BEFORE. REPORTEDLY, THE PHYSICIAN WILL BE REFERRING THE PATIENT TO ANOTHER PHYSICIAN.

  Patient problems: Dysuria; Incontinence; No Code Available; Urinary Retention

  MAUDE report 9689917 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX BLUE SYSTEM WAS USED DURING A RETROPUBIC SLING PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WITHIN THE TIMEOUT, THE PHYSICIAN INJECTED A LOCAL ANESTHESIA AND BEGAN THE INCISION. THE ANESTHESIOLOGIST ASKED THE PHYSICIAN TO STOP AS THEY WERE HAVING AN ISSUE. AFTER FOUR TO FIVE MINUTES, THEY CONTINUED THE PROCEDURE AND PASSED BOTH NEEDLES. THE PHYSICIAN THEN REALIZED THAT HE HAD HIT THE BLADDER WITH ONE OF THE NEEDLES. SUBSEQUENTLY, THE PHYSICIAN TRIED TO PULL THE DEVICE TO RE-PASS IT, AND THE PATIENT BEGAN TO CODE. IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE CAUSE OF THE PATIENT'S DEATH WERE CARDIAC ISSUES AND THE PHYSICIAN DOES NOT BELIEVE THE CARDIAC ISSUES ARE RELATED TO THE DEVICE IN ANY WAY. THE BLOOD LOSS EXPERIENCED BY THE PATIENT WAS REPORTED TO BE MINIMAL. THERE WAS NO MESH PLACED IN THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation

  MAUDE report 9555838 ↗