PEREYRA RAZ LIGATURE CARRIER 090002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for PEREYRA RAZ LIGATURE CARRIER 090002 manufactured by Cook Inc..

Event Text Entries

[87609828] Reporter stated that immediately she received the recall letter regarding the needles, it has been taken out of circulation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072428
• MDR Report Key: 6894007
• Date Received: 2017-09-25
• Date of Report: 2017-09-25
• Date of Event: 2017-04-24
• Date Added to Maude: 2017-09-26
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: PEREYRA RAZ LIGATURE CARRIER
• Generic Name: PEREYRA RAZ LIGATURE CARRIER
• Product Code: GEJ
• Date Received: 2017-09-25
• Catalog Number: 090002
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK INC.

Device Sequence Number: 2

• Brand Name: PEREYRA LIGATURE CARRIER 75
• Generic Name: PEREYRA LIGATURE CARRIER 75
• Product Code: GEJ
• Date Received: 2017-09-25
• Catalog Number: 090100
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COOK INC.

Device Sequence Number: 3

• Brand Name: NEEDLE STAMEY
• Generic Name: NEEDLE STAMEY
• Product Code: GEJ
• Date Received: 2017-09-25
• Catalog Number: 095030
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COOK INC.

Device Sequence Number: 4

• Brand Name: NEEDLE STAMEY
• Generic Name: NEEDLE STAMEY
• Product Code: GEJ
• Date Received: 2017-09-25
• Catalog Number: 095015
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: COOK INC.

Device Sequence Number: 5

• Brand Name: NEEDLE STAMEY
• Generic Name: NEEDLE STAMEY
• Product Code: GEJ
• Date Received: 2017-09-25
• Catalog Number: 095000
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: COOK INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-25