UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-21 for UNK manufactured by Unk.

Event Text Entries

[571258] While physician was performing a d&c, hysteroscopy a perforation was made in the uterus. A diagnostic laparoscopy was performed, no active bleeding was seen. No repair was made, the patient was admitted for overnight observation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	787747
MDR Report Key	787747
Date Received	2006-11-21
Date of Report	2006-11-20
Date of Event	2006-09-22
Date Facility Aware	2006-09-22
Report Date	2006-11-20
Date Reported to FDA	2006-11-20
Date Added to Maude	2006-11-30
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	3
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 Sequence Number: 1

Brand Name	UNK
Generic Name	DEVICE #1 HYSTEROSCOPE
Product Code	HIH
Date Received	2006-11-21
Model Number	UNK
Catalog Number	UNK
Lot Number	UNK
ID Number	UNK
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	775506
Manufacturer	UNK
Manufacturer Address	UNK UNK * *

Device Sequence Number: 2

Brand Name	UNK
Generic Name	DEVICE #2 DILATOR
Product Code	MCR
Date Received	2006-11-21
Model Number	UNK
Catalog Number	UNK
Lot Number	UNK
ID Number	UNK
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	A
Device Sequence No	2
Device Event Key	775509
Manufacturer	UNK
Manufacturer Address	UNK UNK * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-11-21