LAMINARIA 8MM 108

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-10 for LAMINARIA 8MM 108 manufactured by Medgyn Products Inc..

Event Text Entries

[149884] Physician reported pt developed staph infection following use of laminaria (5days). Dr could not confirm that device caused infection. Physician sent medwatch report to mfr on friday 14 july after normal hours.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1450908-2000-00001
• MDR Report Key: 293262
• Date Received: 2000-08-10
• Date of Report: 2000-08-04
• Device Manufacturer Date: 1999-04-01
• Date Added to Maude: 2000-08-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NO
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LAMINARIA
• Generic Name: UTERINE DIALATOR
• Product Code: HDY
• Date Received: 2000-08-10
• Model Number: 8MM
• Catalog Number: 108
• Lot Number: 102691
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 283860
• Manufacturer: MEDGYN PRODUCTS INC.
• Manufacturer Address: 328 N. EISENHOWER LN LOMBARD IL 60148 US
• Baseline Brand Name: LAMINARIA
• Baseline Generic Name: UTERINE DIALATOR
• Baseline Model No: 8MM
• Baseline Catalog No: 108
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2000-08-10