FDA Adverse Event Injury Summary report: N

DILAPAN-S

MDR report key: 20187800 · Received September 11, 2024

Report

Report Number
3003994796-2024-00003
Event Type
Injury
Date Received
September 11, 2024
Date of Event
August 18, 2024
Report Date
September 11, 2024
Manufacturer
MEDICEM TECHNOLOGY S.R.O.
Product Code
PKN
PMA / PMN Number
K143447
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

EVENT DESCRIPTION: A PATIENT INDUCED FOR INDUCTION OF LABOUR (IOL) WITH 5 DILATORS INSERTED, DURING REMOVAL ONLY 4 DILATORS REMOVED, ONE DILATOR MISSING. THE HEALTHCARE PROFESSIONAL (HCP) DECIDED NOT TO PERFORM AN ULTRASOUND SCAN. BABY DELIVERED VIA CS (REASON: MATERNAL REQUEST), CAVITY EMPTY, THE MISSING DILATOR WAS NOT FOUND. NO SCAN PERFORMED POSTNATALLY, THE PATIENT WAS DISCHARGED HOME - THE HCP PROBABLY ASSUMED THE DILATOR MUST HAVE FALLEN OUT PRIOR TO REMOVAL. THE MISSING DILATOR PASSED AT HOME AROUND 2 DAYS LATER AS REPORTED BY A COMMUNITY MIDWIFE DURING POSTNATAL CHECK OF THE PATIENT. THE PATIENT WAS WELL, NO SIGNS OF INFECTION. CONCLUSION OF INVESTIGATION: THE HCP WRONGLY ASSUMED THE MISSING DILATOR MUST HAVE FALLEN OUT PRIOR TO REMOVAL. NEITHER ULTRASOUND SCAN WAS PERFORMED WHEN MISSING THE DILATOR (1 OF 4) AFTER REMOVAL NOR POSTNATALLY, ALTHOUGH IT IS A RECOMMENDED PROCEDURE FOR CASES WHEN THE DILATOR HAS SOMEHOW MIGRATED OR BEEN DISPLACED OUTSIDE CERVICAL CANAL. THE REASON FOR REPORTING IS THE POTENTIAL RISK OF INFECTION WHEN THE PATIENT WAS DISCHARGED HOME WITH THE DILATOR IN HER BODY (SIGNIFICANTLY LONGER THAN 24 HOURS).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2021343 DILAPAN-S Dilator, cervical, synthetic, osmotic PKN MEDICEM TECHNOLOGY S.R.O.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other