DILAPAN, 3 MM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-26 for DILAPAN, 3 MM manufactured by Gynotech, Inc..

Event Text Entries

[16619402] A 3 mm cervical dilator was inserted on 12/5/94, in preparation for an abortion. Four hours later an attempt was made to remove it. It broke rptr was unable to remove it that day. Rptr finally was able to receive it the next day in pieces, and complete the abortion. When the dilator broke, it broke proximate to the external cervidal os. It so filled the os that ring forceps, uterine packing forceps, and various other instruments were unable to grasp the broken piece. They were afraid to push it in because once before he did that and was not able to remove it. (the pt eventually passed it on her own. ) (that case was reported to mfr. ) when the broken piece was finally removed the next day, it fragmented making certainty of complete removal difficult. Overnight rptr kept the pt on antibiotics to prevent infection. Rptr has had these devices break before he called up the company and was told they were "designed" to break to keep from damaging the cervix but mfr rep was unable to provide rptr the result on documentation in this area. He does not understand why they were "designed" to break unless there is clear documentation of benefit. Certainly this caused considerable frustation and delays for both physician and pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1004888
• MDR Report Key: 19175
• Date Received: 1995-01-27
• Date of Report: 1995-01-03
• Date of Event: 1994-12-05
• Date Added to Maude: 1995-01-27
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DILAPAN, 3 MM
• Generic Name: CERVICAL DILATOR
• Product Code: MCR
• Date Received: 1995-01-26
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 19098
• Manufacturer: GYNOTECH, INC.
• Manufacturer Address: MIDDLESOX NJ 08846 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1995-01-27