GYNOTECH SIZE 4MM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-02 for GYNOTECH SIZE 4MM manufactured by Gynotech, Inc..

Event Text Entries

[16472377] Dilapan laminaria inserted on 10/5/92. Upon removal from cervix on 10/6/92. Distal portion of laminaria fragmented in the patient. All visible significant fragments were retreived by physician. Patient informed. To date, patient has had no complications related to this event. Physician feels that the patient's anatomical constricture of the cervical canal may have contributed to the eventdevice 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: maybe. Corrective actions: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3893
• MDR Report Key: 3893
• Date Received: 1993-02-02
• Date of Report: 1992-11-06
• Date of Event: 1992-10-06
• Date Facility Aware: 1992-10-06
• Report Date: 1992-11-06
• Date Reported to FDA: 1992-11-06
• Date Reported to Mfgr: 1992-11-06
• Date Added to Maude: 1993-05-07
• 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: GYNOTECH
• Generic Name: DILAPAN LAMINARIA
• Product Code: HDY
• Date Received: 1993-02-02
• Model Number: SIZE 4MM
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3633
• Manufacturer: GYNOTECH, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-02