FDA Adverse Event Injury Summary report: N

DILAPAN-S

MDR report key: 20244647 · Received September 18, 2024

Report

Report Number
3003994796-2024-00004
Event Type
Injury
Date Received
September 18, 2024
Date of Event
August 30, 2024
Report Date
September 18, 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: THE PATIENT INDICATED FOR IOL (INDUCTION OF LABOUR) DUE TO PRE-ECLAMPSIA USING DILAPAN-S. ON (B)(6) 2024 AT 18:35 VAGINAL EXAMINATION (VE) PERFORMED: CERVIX 1CM DILATED, 1-2CM LONG, POSTERIOR, PRESENTING PART AT -3 TO SPINES, MODIFIED BISHOPS SCORE OF 4, THE HEALTH CARE PROFESSIONAL (HCP) INSERTED FOUR RODS OF DILAPAN-S DIGITALLY WITH SPONGE HOLDING FORCEPS AS PART OF INDUCTION PROCESS. AT 19:00 THE PATIENT REPORTED RUPTURE OF MEMBRANES. AT 23:40 THE HCP REMOVED THREE RODS, 4TH ROD MISSING - SPECULUM EXAMINATION PERFORMED TO TRY AND LOCATE THE 4TH ROD, BUT NO ROD FOUND. ON (B)(6) 2024 AT 11:30 USS TRANSVAGINAL EXAMINATION PERFORMED, UNABLE TO LOCATE 4TH ROD ON SCAN. AT 11:45 VE PERFORMED: PATIENT 2CM DILATED, MID POSITION, 1CM LONG, ARM PERFORMED WITH CLEAR LIQUOR. AT 12:50 THE HCP (AFTER DISCUSSION AND OBTAINING THE PATIENT'S CONSENT) DECIDED TO PERFORM A CAESAREAN SECTION (CS) DUE TO UNCERTAINTY OF LOCATION OF THE 4TH ROD. AT 16:00 THE PATIENT HAD UNCOMPLICATED LOWER SEGMENT CS, 4TH ROD LOCATED DURING PROCEDURE IN THE UTERINE CAVITY. CONCLUSION OF INVESTIGATION: NO QUALITATIVE ISSUE. MIGRATION OF THE DILATORS (DEVICE RETRACTION INTO THE UTERUS) IS A POSSIBLE COMPLICATION THAT MAY OCCUR DURING THE PROCEDURE. THE DECISION ABOUT CS WAS DONE BY THE RESPONSIBLE HCP BASED ON THE PATIENT'S PREFERENCE, MEDICAL CONDITIONS AND PHARMACOLOGICAL INTERVENTION AFTER EVALUATION OF POSSIBLE OPTIONS AND RELATED RISKS FOR THE PATIENT. NO CONCERNS ABOUT DETERIORATION IN STATE OF HEALTH OF THE PATIENT OR BABY. HOWEVER, THE IMPOSSIBILITY TO LOCATE/RETRIEVE THE MIGRATED DILATORS MIGHT CONTRIBUTE TO THE CS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1346024 DILAPAN-S Dilator, cervical, synthetic, osmotic PKN MEDICEM TECHNOLOGY S.R.O.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other