MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS GREAT RIVER MEDICAL CENTER D & C VAG HYST PACK; GYNECOLOGICAL LAPAROSCOPIC KIT

Catalog Number	GDC79C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Hair found in custom d & c vag hyst pack when opened.Was on top of prep tray.Fda safety report id# (b)(4).

• Brand Name: GREAT RIVER MEDICAL CENTER D & C VAG HYST PACK
• Common Device Name: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS
• MDR Report Key: 8772727
• Report Number: MW5087959
• Device Sequence Number: 13929376
• Product Code: OHD
• UDI-Device Identifier: 00191072042361
• UDI-Public: 00191072042361
• 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: 04/12/2020
• Device Catalogue Number: GDC79C
• Device Lot Number: 898191
• 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