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

Catalog Number PROMESHUNK

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: international journal of urology (2006) 13, 1249¿1250.Please see article attached.(b)(4).

Event Description

It was reported in a journal article with title: surgical mesh used for an inguinal herniorrhaphy acting as a nidus for a bladder calculus.This is a case report concerning a (b)(6) year old male patient who was presented in the hospital with persistent urinary infection.The patient complained of nocturia 15-20 times a night, minimal dysuria, and occasional macroscopic hematuria.Mid-stream urine culture revealed a heavy growth of escherichia coli.The patient¿s past history included a laparoscopic prolene mesh (ethicon) repair of a right inguinal hernia in 1992 followed by a similar procedure for a left inguinal hernia in 1994.Bladder ultrasound revealed large prostate with calcification of middle lobe and in cystourethroscopy, it was revealed mildly enlarged prostate but showed large bladder calculus.The size of the calculus precluded endoscopic removal and therefore an elective open vesiculo-lithotomy was subsequently carried out via a pfannenstiel incision.Further, a 10 cm calculus was found densely adherent to the right bladder wall.It was apparent that the calculus had formed a nidus of mesh which had previously been used for a hernia repair.The calculus was removed after excision of the mesh from the bladder and adjacent tissues.The defect in the bladder was then closed and both suprapubic and urethral catheters were inserted.Mesh migration and erosion into adjacent viscera is a well-known late complication of mesh repair.The author reported that it is likely in this case that the calculus formed on a small nidus on the eroded mesh which then increased in size, gradually incorporating the whole mesh within the calculus.

• 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8953918
• MDR Text Key: 156451971
• Report Number: 2210968-2019-86466
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• 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): Required Intervention
• Patient Age: 64 YR