LAMINARIA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-11 for LAMINARIA * manufactured by *.

Event Text Entries

[21633251] 7/9/97: temperature 98 degrees. 7/10/97: temperature 98. 2 degrees. Per pt went to er 7/11 c/o feeling hot/chills. Admitted to r/o endometritis, r/o retained products of conception 2. Uti, r/o pyelonephritis temp 100. 8 iv antibiotics given discharge 7/16/97 endometritis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 118825
• MDR Report Key: 118825
• Date Received: 1997-09-11
• Date of Report: 1997-09-09
• Date of Event: 1997-07-09
• Date Facility Aware: 1997-08-08
• Report Date: 1997-09-09
• Date Reported to Mfgr: 1997-09-09
• Date Added to Maude: 1997-09-12
• 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: LAMINARIA
• Generic Name: *
• Product Code: HDY
• Date Received: 1997-09-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 116503
• Manufacturer: *
• Manufacturer Address: * * *
• Baseline Brand Name: BUSSE LAMINARIA
• Baseline Generic Name: SINGLE USE 3 MM CERVICAL DILATOR, DISPOSABLE
• Baseline Model No: 3 MM SIZE
• Baseline Catalog No: 206
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-09-11