GYNOSAMPLER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for GYNOSAMPLER manufactured by Homesteel - Achel N.v..

Event Text Entries

[6276] Physician performed endometrial biopsy on 11/16/93. Results negative. Pt called physician on 11/17/93 stating she had abdominal pain and fever. She was admitted tohospital. Cervical culture, urine culture, and blood culture were performed. Pt was diagnosed with beta-strep infection of cervix. She was treated with rocephin, flagyl, and erthromycin. She was also given tylenol with codeine for pain. Pt was discharged fromhospital 11/22/93. She is doing much better. She did develop an allergy to one of the antibiotics. Physician is not sure which one. She is scheduled for follow-up exam in one week.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	2246681-1993-00001
MDR Report Key	17238
Date Received	1994-01-10
Date of Report	1993-12-03
Date of Event	1993-11-17
Date Facility Aware	1993-11-23
Report Date	1993-12-03
Date Reported to FDA	1993-12-03
Date Added to Maude	1994-10-28
Event Key	0
Report Source Code	Distributor 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	GYNOSAMPLER
Generic Name	ENDOMETRICAL ASPIRATOR
Product Code	HFF
Date Received	1994-01-10
Model Number	NA
Catalog Number	NA
Lot Number	NI
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	B
Device Sequence No	1
Device Event Key	17171
Manufacturer	HOMESTEEL - ACHEL N.V.
Manufacturer Address	*

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-01-10