MAUDE Adverse Event Report: APPLIED MEDICAL GELPOINT MINI ADVANCE ACCESS PLATFORM

Lot Number 1300433

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Gelpoint mini product broke while in use by the physician.

• Brand Name: GELPOINT MINI ADVANCE ACCESS PLATFORM
• Type of Device: GELPOINT MINI
• Manufacturer (Section D): APPLIED MEDICAL; rancho santa margarita CA 92688
• MDR Report Key: 7027727
• MDR Text Key: 92043612
• Report Number: MW5073319
• Device Sequence Number: 1
• Product Code: HEW
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Lot Number: 1300433
• 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): Other
• Patient Age: 27 YR