MAUDE Adverse Event Report: DAVOL INC. VENTRALIGHT; MESH, SURGICAL, POLYMERIC

Model Number	5955450
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part of the inflator system (yellow hub) came off mesh & into patient.Removed from patient.No problem completing case.Manufacturer response for mesh, surgical, polymeric, ventralight st mesh with echo ps positoning system (per site reporter).Manufacturer issued rga#.

• Brand Name: VENTRALIGHT
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC.; 160 new boston st; woburn MA 01801
• MDR Report Key: 20557154
• Report Number: 20557154
• Device Sequence Number: 8886332
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2024
• Report Date (Section F): 08/01/2024

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 Model Number: 5955450
• Device Catalogue Number: 5955450
• Device Lot Number: HUJP1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/01/2024