MAUDE Adverse Event Report: INDEPENDENT MEDICAL CO-OP, INC. IMCO; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	J494-IMC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Needle broke during normal use.

• Brand Name: IMCO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): INDEPENDENT MEDICAL CO-OP, INC.; 11145 inland ave; mira loma CA 91752
• MDR Report Key: 9167352
• Report Number: 9167352
• Device Sequence Number: 14146832
• Product Code: GAM
• UDI-Device Identifier: 00815842021607
• UDI-Public: (01)00815842021607
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/18/2019
• Report Date (Section F): 09/18/2019

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 Model Number: J494-IMC
• Device Lot Number: PGZ711
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 85
• Date Report Sent to FDA: 09/18/2019