MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS GRHS CUSTOM MINOR PACK; GENERAL SURGERY TRAY

Catalog Number GIMI55C

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Hair in custom raytec pack.Fda safety report id# (b)(4).

• Brand Name: GRHS CUSTOM MINOR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS
• MDR Report Key: 8624526
• MDR Text Key: 145684539
• Report Number: MW5086753
• Device Sequence Number: 1
• Product Code: LRO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Catalogue Number: GIMI55C
• Device Lot Number: 936191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention