DILAPAN LAMINARIA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-20 for DILAPAN LAMINARIA manufactured by Gynotech.

Event Text Entries

[15008690] Dilapan laminaria inserted 2/19/92. Upon removal of laminaria from cervix on 2/20/92, laminaria broke into multiple pieces. According tophysician, all pieces were removed. Pieces were not saved. Packaging had been discarded the previous day, so that lot # serial # could not be identified. Physician visually inspected the pieces to determine that all pieces were retreiveddevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: no. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4135
• MDR Report Key: 4135
• Date Received: 1992-07-20
• Date of Report: 1992-03-11
• Date of Event: 1992-02-20
• Date Facility Aware: 1992-02-20
• Report Date: 1992-03-11
• Date Reported to Mfgr: 1992-03-11
• Date Added to Maude: 1993-05-14
• 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: 0
• Initial Report to FDA: 0
• 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 LAMINARIA
• Generic Name: CERVICAL DILATOR
• Product Code: HDY
• Date Received: 1992-07-20
• Operator: OTHER CAREGIVERS
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3868
• Manufacturer: GYNOTECH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-20