MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. GELPOINT MINI ADVANCED ACCESS PLATFORM; CULDOSCOPE (AND ACCESSORIES)

Lot Number 1348491

Device Problem Device Fell (4014)

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

Event Date 05/14/2019

Event Type  Injury  

Event Description

Clear plastic fell apart and into pt from gelpoint mini advanced access platform.Fda safety report id# (b)(4).

• Brand Name: GELPOINT MINI ADVANCED ACCESS PLATFORM
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP. ; rancho santa margarita CA 92688
• MDR Report Key: 8683765
• MDR Text Key: 147583734
• Report Number: MW5087222
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 10607915131781
• UDI-Public: 01106079151317811722030430011013
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Lot Number: 1348491
• 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
• Patient Age: 52 YR