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

Catalog Number GDC79C

Device Problem Microbial Contamination of Device (2303)

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

Event Date 06/28/2019

Event Type  Injury  

Event 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
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS
• MDR Report Key: 8772727
• MDR Text Key: 150596949
• Report Number: MW5087959
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 00191072042361
• UDI-Public: 00191072042361
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: GDC79C
• Device Lot Number: 898191
• Was Device Available for Evaluation?: Yes
• 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