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

Model Number GICS36D 2

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

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

Event Date 05/08/2019

Event Type  Injury  

Event Description

Hair found in pack when setting up for scheduled c-section.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; minneapolis MN 55437
• MDR Report Key: 8627878
• MDR Text Key: 145836942
• Report Number: MW5086790
• 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: 03/06/2020
• Device Model Number: GICS36D 2
• Device Lot Number: 935191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 88