MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Hernia (2240); Ambulation Difficulties (2544); Not Applicable (3189)

Event Date 05/18/2018

Event Type  Injury  

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. Additional information was requested, and the following was obtained: the patient is no longer working due to pain and is now on antibiotics and other unspecified medications. The patient is also experiencing walking difficulty and pain discomfort with laying down. No additional information will be provided at this time. How are you currently feeling? 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? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

Event Description

It was reported that the patient underwent an incarcerated inguinal hernia repair procedure on (b)(6) 2017 and the mesh was implanted. The patient underwent a surgery again in (b)(6) 2018. Then the patient was re-hospitalized in (b)(6) 2018 with swollen prostate. It was also reported by the patient that he is no longer working due to pain and is now on antibiotics and other unspecified medications. The patient is also experiencing walking difficulty and pain discomfort with laying down. No further information is available.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7725074
• Report Number: 2210968-2018-74657
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention