MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS CUSTOM SPINAL PACK; GENERAL SURGICAL TRAY

Catalog Number	GISP56B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Hair found on back table cover of custom spinal pack.Fda safety report id # (b)(4).

• Brand Name: CUSTOM SPINAL PACK
• Common Device Name: GENERAL SURGICAL TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; minneapolis MN 55437
• MDR Report Key: 8772272
• Report Number: MW5087943
• Device Sequence Number: 19290749
• Product Code: LRO
• UDI-Device Identifier: 00191072004109
• UDI-Public: 00191072004109
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: GISP56B
• Device Lot Number: 880191
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention