SELECTCELLS STANDARD ENDOMETRIAL SAMPLING DEVICE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-09 for SELECTCELLS STANDARD ENDOMETRIAL SAMPLING DEVICE * manufactured by Select Medical Systems, Inc..

Event Text Entries

[21954223] Device appears to have been mfg and distributed without a lot control number and without an expiration date for the sterilization of the device. Also, although the tyvek pouch asserts "refer to directions for use for detailed instructions", no detailed instructions were provided with the device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4001632
• MDR Report Key: 42138
• Date Received: 1996-10-09
• Date of Report: 1996-07-30
• Date Added to Maude: 1996-10-16
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SELECTCELLS STANDARD ENDOMETRIAL SAMPLING DEVICE
• Generic Name: ENDOMETRIAL SAMPLING DEVICE
• Product Code: HHK
• Date Received: 1996-10-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 43178
• Manufacturer: SELECT MEDICAL SYSTEMS, INC.
• Manufacturer Address: 2 WINTER SPORT LANE WILLISTON VT 05495 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-10-09