MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8699G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the following information.To date no response has been provided.If further details and or the device are received at a later date a supplemental medwatch will be sent.Were the sutures breaking during the procedure (intra-op) or post -op? how many procedures were involved in the complaint- 'the 8699g (three boxes) sutures are breaking in the patients'? were all previous events reported to ethicon? if yes, please provide complaint reference numbers if no, please inform the following information separately for each event date procedure name event description (include - when did the suture breakage issue occurred) what consequences did the patient suffer? if issue occurred post -op, how many days post-op did the sutures found broken? what medical/surgical intervention was provided to manage the patient consequences? patients current condition.A shipper kit will be mailed to you to return of the product.Please provide product return status.Please clarify the lot.The lot provided does not correspond to reported product code: 8699g / prolene suture.Lot mjk059 corresponding to product code j497g / vicryl suture.
Event or Problem Description
It was reported a patient underwent an unknown dermatology procedure on an unknown date and suture was used.The sutures are breaking in the patients.It is unknown if another like device was used to complete the procedure.An unknown injury may have occurred and additional information has been requested.

• Brand Name: PROLENE SUTURE 18"(45CM) 4-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8474419
• Report Number: 2210968-2019-79905
• Device Sequence Number: 1629006
• Product Code: GAW
• UDI-Device Identifier: 10705031019263
• UDI-Public: 10705031019263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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 Catalogue Number: 8699G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/02/2019
• Patient Sequence Number: 1