MAUDE Adverse Event Report: COOK INC. PEREYRA RAZ LIGATURE CARRIER

Catalog Number 090002

Device Problem Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2017

Event Type  No Answer Provided  

Event Description

Reporter stated that immediately she received the recall letter regarding the needles, it has been taken out of circulation.

• Brand Name: PEREYRA RAZ LIGATURE CARRIER
• Type of Device: PEREYRA RAZ LIGATURE CARRIER
• Manufacturer (Section D): COOK INC.
• MDR Report Key: 6894007
• MDR Text Key: 87609828
• Report Number: MW5072428
• Device Sequence Number: 1
• Product Code: GEJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 090002
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1