MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A P-2 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J503G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an eye lid procedure in (b)(6) 2021 and suture was used.During the procedure, the needle broke off and could not be found.After 30 minutes, it was found inside of the eye socket.No adverse patient consequences were reported.No additional information was provided.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A P-2 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11436974
• Report Number: 2210968-2021-02094
• Device Sequence Number: 14292596
• Product Code: GAM
• UDI-Device Identifier: 10705031040717
• UDI-Public: 10705031040717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: J503G
• Device Catalogue Number: J503G
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1