MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the initial procedure? what is the event day and procedure date? was any surgical intervention performed specially re-suturing? explain.On what tissue was the suture placed? what was tissue condition? were any prescribed medications required? please specify them.Did the patient suffer from wound secretion, infection or wound dehiscence? please explain.Were there any alleged deficiencies noted with the device that could have contributed to the patient¿s post-operative complications as mentioned in the event description? could you please confirm device's availability? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The sutures opened in less than three days leaving the implant exposed.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: VCL+ UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11262658
• Report Number: 2210968-2021-00864
• Device Sequence Number: 16958055
• Product Code: GAM
• UDI-Device Identifier: 10705031053694
• UDI-Public: 10705031053694
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2021

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 Expiration Date: 10/31/2024
• Device Model Number: VCP494G
• Device Catalogue Number: VCP494G
• Device Lot Number: PMM796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2021
• Initial Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1