* SLR-EIS8-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-09 for * SLR-EIS8-5 manufactured by Alco Industries.

Event Text Entries

[18913083] Human embryos being prepped for freeze. Tips of straws containing embryos were heat sealed and then frozen. During thaw it was found that the straws were empty of the contents.
Patient Sequence No: 1, Text Type: D, B5

[19051023] Human embryos being prepped for freeze. Tips of straws containing embryos were heat sealed and then frozen. During thaw it was found that the straws were empty of the contents.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1495680
• MDR Report Key: 1495680
• Date Received: 2009-09-09
• Date of Report: 2009-09-09
• Date of Event: 2009-05-05
• Report Date: 2009-09-09
• Date Reported to FDA: 2009-09-09
• Date Added to Maude: 2009-10-08
• 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
• Reporter Occupation: RISK MANAGER
• 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: *
• Generic Name: HEAT SEALER
• Product Code: KSD
• Date Received: 2009-09-09
• Model Number: *
• Catalog Number: SLR-EIS8-5
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Age: 47 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCO INDUSTRIES
• Manufacturer Address: 6340 ARTESIA BLVD BUNEA PARK CA 90620 US 90620

Device Sequence Number: 2

• Brand Name: CRYOTIP STRAWS
• Generic Name: EMBRYO PRESERVATION
• Product Code: OOF
• Date Received: 2009-09-09
• Model Number: *
• Catalog Number: *
• Lot Number: T-025A, T-018A, T022A
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: IRVINE SCIENTIFIC
• Manufacturer Address: 2511 DAIMLER STREET SANTA ANA CA 92705558 US 92705 5588

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2009-09-09