MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* HERNIA SYSTEM MESH 1; MESH, SURGICAL, POLYMERIC

Catalog Number UHSM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Hypoesthesia (2352); Not Applicable (3189)

Event Date 08/01/2015

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.

Event Description

It was reported that the patient underwent an inguinal hernia repair procedure on an unknown date and mesh was implanted.The patient has experienced pain since the initial procedure and underwent a hysterectomy as a result.No additional information has been provided.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).Date sent to the fda: 03/24/2019.Additional information was received: pain persist on area since surgery 2015 beneath skin left side were the mesh was placed.Pulling stabbing numbness burning hurts to the touch with any movement expanding down my leg inner thigh.When did this happen? (b)(6) 2015.Please describe the injury: chronic pain in the left groin area down my leg.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7070873
• MDR Text Key: 93335351
• Report Number: 2210968-2017-71504
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: UHSM
• Device Lot Number: HP8DDXA1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2019
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1