MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS GRHS CUSTOM C-SECTION PACK; CESAREAN SECTION TRAY

Catalog Number GICS36D 1

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

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

Event Date 04/07/2019

Event Type  malfunction  

Event Description

Hair found in custom c-section pack while setting up case.Fda safety report id# (b)(4).

• Brand Name: GRHS CUSTOM C-SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; MO
• MDR Report Key: 8624217
• MDR Text Key: 145739575
• Report Number: MW5086751
• Device Sequence Number: 1
• Product Code: OHM
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Catalogue Number: GICS36D 1
• Device Lot Number: 990191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2019
• 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 Age: 20 YR
• Patient Weight: 53