MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL, POLYMERIC

Catalog Number	PHY1520V
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of maude event report mw5077106.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2010 and the mesh was implanted over an aortobifemoral bypass incisional hernia that measured 2.5cm.Two weeks later, the mesh was removed on (b)(6) 2010 as well as abdominal muscles, nerves, and belly button.It was also reported that there was no pathology report done because the organism which caused of infection was known.It was also reported that the patient experienced bowel obstruction from scar tissue from two prior surgeries.Additional information has been requested.
Additional Manufacturer Narrative
Pc-000211825 date sent to the fda: 07/29/2018 corrected information: additional information: additional method codes: additional result codes: corrected conclusion codes: the review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7657446
• Report Number: 2210968-2018-74012
• Device Sequence Number: 18870095
• Product Code: FTL
• UDI-Device Identifier: 10705031132337
• UDI-Public: 10705031132337
• Combination Product (Y/N): N
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 06/30/2011
• Device Catalogue Number: PHY1520V
• Device Lot Number: CJ9GDQZ0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention