MAUDE Adverse Event Report: ETHICON INC. GYNEMESH PSXL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	GPSXL3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Septic Shock (2068)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch number: batch (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 the patient underwent laparoscopic sacrocolpopexy on (b)(6) 2017 and mesh was implanted.Following the procedure, the patient had septic shock and sepsis occurred immediately after surgery.It was reported that the blood state was already bad and the leukocyte count was rising during the operation.The patient was provided treatment for sepsis with vasopressor drug, blood circulation, ventilator.The patient was admitted to icu and currently the blood condition is reported to be pretty bad.The surgeon opined there was no cause and relationship between mesh and sepsis.The patient is in the hospital.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/14/2018 the device history records were reviewed for the possible batch number and the manufacturing criteria was met prior to the release of this lot.Batch ljb191; mfg.Date: 08/01/2017; exp.Date: 07/31/2022.

• Brand Name: GYNEMESH PSXL MESH
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7212545
• Report Number: 2210968-2018-70406
• Device Sequence Number: 13483356
• Product Code: OTO
• UDI-Device Identifier: 10705031037748
• UDI-Public: 10705031037748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2017

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 Catalogue Number: GPSXL3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention