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

Lot Number	1348491
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP. ; rancho santa margarita CA 92688
• MDR Report Key: 8683765
• Report Number: MW5087222
• Device Sequence Number: 2372561
• Product Code: HEW
• UDI-Device Identifier: 10607915131781
• UDI-Public: 01106079151317811722030430011013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 04/03/2022
• Device Lot Number: 1348491
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2019
• 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
• Patient Age: 52 YR