Description of Event or Problem · 0
A PATIENT INDUCED FOR IOL (5 RODS OF DILAPAN-S INSERTED). THE EXACT DATE OF THE EVENT IS NOT KNOWN; HOWEVER, THE CASE PROBABLY HAPPENED BETWEEN (B)(6) 2025. AT 8 P.M. (APPROXIMATELY): INSERTION OF 5 RODS, STARTING EXAM 1 CM/LONG/POSTERIOR, THE PLACEMENT WAS MILDLY DIFFICULT DUE TO LATERAL SIDE WALL INTERFERENCE. A DIGITAL EXAM AFTER REMOVING THE SPECULUM CONFIRMED THAT ALL FIVE RODS WERE INSERTED AND FLUSH WITH THE EXTERNAL OS. THE PATIENT WAS THEN DISCHARGED HOME. AT 2 A.M.: THE PATIENT REPORTED TO THE CERTIFIED NURSE MIDWIFE (CNM), SHE WOKE UP WITH A BOWEL MOVEMENT (BM). SHE DID NOT CHECK THE TOILET BECAUSE SHE WAS TIRED. SOON AFTER, HEADED TO THE HOSPITAL, WHERE PER CNM, THE PATIENT PRECIPITOUSLY DELIVERED AN INFANT EN CAUL, THEN DELIVERED PLACENTA WITH NO ADDITIONAL BLEEDING. NO RODS WERE FOUND AT THAT TIME. THE CNM SUSPECTED THE RODS MAY HAVE BEEN EXPELLED DURING THE BM. 36 HOURS LATER (APPROXIMATELY): WHILE WALKING ON THE POSTPARTUM UNIT, THE PATIENT FELT SOMETHING FALL ONTO HER PAD AND DISCOVERED 4 RODS OF DILAPAN-S. A TRANSVAGINAL ULTRASOUND WAS PERFORMED AT THAT TIME, AND THE 5TH ROD WAS NOT VISUALIZED OR FOUND. THE REASON FOR REPORTING IS A POTENTIAL RISK OF INFECTION, BECAUSE THE DILATORS REMAINED IN THE BODY SIGNIFICANTLY LONGER THAN 24 HOURS, WHEN THE PATIENT WAS LEFT WITH THE DILATOR IN SITU. SUPPORTING ASPECT IS VERIFICATION OF RODS PRESENCE OR ABSENCE AFTER DELIVERY. BASED ON THE NATURE OF THE EVENT, THE LIKELIHOOD OF A QUALITATIVE DEFECT IN THE DEVICE IS CONSIDERED NEGLIGIBLE. WHILE THE BATCH NUMBER OF THE DEVICE INVOLVED IS NOT KNOWN, THIS DOES NOT IMPACT THE ASSESSMENT, AS NO QUALITATIVE DEFECT IS SUSPECTED.