MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE SMALL 6CM X 11CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMS3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Neuropathy (1983); Pain (1994); Hypoesthesia (2352); Ambulation Difficulties (2544)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the patient that they underwent hernia procedure in (b)(6) 1998 and mesh was implanted to repair small reducible inguinal hernia.Following the procedure, the patient reported it has caused the following symptoms, that started after having a hysterectomy in 2012: ¿neuropathy; rashes; sinus; fatigue; feeling poisoned; eyes, dry, blurred vision; gums, receding, taste, dry mouth; sore throat; chest pain.Heartburn sternum pain; pains; numbness; groin, legs, sharp pains - electric/brambles; joint stiffness; bladder, weird sensations; tells lies; leaks; numbness over wound site; brain fog; memory loss; walking/clumsy; hot sweats; hands - dropping things; bowels, prolapse; dyspareunia¿.The patient reported that ¿these have all developed at different rates over the years.The degree of effect of each symptom can vary from day to day.It's taken a few years to get to the cause of it all, but i have just seen a consultant who said that the symptoms i have are in line with the complications of mesh and that it needs removing.¿ no additional information was provided.

• Brand Name: MALLA PROLENE SMALL 6CM X 11CM
• 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; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8334109
• MDR Text Key: 135995594
• Report Number: 2210968-2019-78777
• 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,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PMS3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• 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): Other