MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLY HERNIA; MESH, SURGICAL, POLYMERIC

Catalog Number PHSL

Device Problem Detachment Of Device Component (1104)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(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.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.If in your possession, may we have a copy of your operative report for the revision surgery? does ethicon have your permission to contact your surgeon that performed the revision surgery, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.

Event Description

It was reported by the patient that they underwent a surgical procedure on (b)(6) 2010 and mesh was implanted.Following the procedure, the patient was having complications.The patient underwent a revision surgery to have the mesh removed and hernia repaired again.The patient was informed that the mesh was not attached and was balled up on top of the hernia.The patient reports no complications after the hernia revision surgery.Additional information has been requested.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. .

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.- J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7636037
• MDR Text Key: 112282566
• Report Number: 2210968-2018-73757
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048966
• UDI-Public: 10705031048966
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHSL
• Device Lot Number: 21073-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 116