MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 36"(90CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP917H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being made to retrieve the device.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.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.The patient demographic info: age, weight, bmi at the time of index procedure what tissue location of the placement of suture? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was suture initially placed (interrupted or continuous)? please explain why the physician believed the suture did not absorb well.What was the appearance of the suture during the second procedure? other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status?.
Event or Problem Description
It was reported that the patient underwent physiological delivery on (b)(6) 2018 and suture was used.On (b)(6) 2018, the patient complained of pain.The patient¿s symptoms were relieved after suture removal.The healthcare professional opined the suture did not absorb well.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Additional information was requested and the following was obtained: please explain why the physician believed the suture did not absorb well.The suture didn't become soft as before what is physician¿s opinion as to the etiology of or contributing factors to this event? maybe suture what is the patient current status? stable the following information was requested but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure what tissue location of the placement of suture? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was suture initially placed (interrupted or continuous)? what was the appearance of the suture during the second procedure? other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information? an unopened sample of product code (b)(4), lot # kj7132 was returned for analysis.The issue sample was not returned for analysis.The representative sample was examined for visual defects: appearance, color packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packet was opened and during the visual inspection, the suture was correctly placed on the winding former, the suture was dispensed without problems and examined along of the strand and no defects or damage was observed, the suture did not present defects.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause cannot be determined since no defects were observed on the packet or the suture.

• Brand Name: VICRYL PLUS SUTURE 36"(90CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8011126
• Report Number: 2210968-2018-76792
• Device Sequence Number: 19158085
• Product Code: GAM
• UDI-Device Identifier: 10705031056039
• UDI-Public: 10705031056039
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: VCP917H
• Device Lot Number: KJ7132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 11/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention