DILAPAN HYGROSCOPIC CERVICAL DILATOR PT #4480642 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-17 for DILAPAN HYGROSCOPIC CERVICAL DILATOR PT #4480642 * manufactured by Gynotech, Inc.

Event Text Entries

[92431] Cervical dilator broke apart during removal requiring mini-lap to remove dilator from cervix.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 149967
• MDR Report Key: 149967
• Date Received: 1998-02-17
• Date of Report: 1998-02-11
• Date of Event: 1998-02-10
• Date Facility Aware: 1998-02-10
• Report Date: 1998-02-11
• Date Added to Maude: 1998-02-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DILAPAN HYGROSCOPIC CERVICAL DILATOR
• Generic Name: SPA WEED CERVICAL DILATOR
• Product Code: MCR
• Date Received: 1998-02-17
• Model Number: PT #4480642
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 146132
• Manufacturer: GYNOTECH, INC
• Manufacturer Address: PO BOX 355 MIDDLESEX NJ 08846 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-02-17