MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number ULTRAPLUGUNK

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

Patient Problems 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: hernia (2017) 21 (suppl 2):s208¿s263.The following information was requested, but unavailable: was this case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (ultrapro hernia plug) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (ultrapro hernia plug) involved? (b)(4).

Event Description

It was reported in a journal article with title: a case of mesh perforation into the bladder following inguinal hernia repair.This case study aimed to present a (b)(6) year old male patient who had recurrence of right inguinal hernia underwent right laparoscopic hernioplasty using anterior approach with an ultrapro plug (ethicon).Since surgery, the patient had continuous hematuria and cystoscopic observation indicated that the mesh had been displaced.He underwent a partial cystectomy and partial mesh resection in which cystotomy was performed and resection of the anchor part of the plug that was displaced.No complications postoperatively and progress was good, the patient was discharged on day 25 post admission.

• Brand Name: ULTRAPRO HERNIA PLUG 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.-GMBH; robert-koch strasse 1; norderstedt 22851 ; GM 22851
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8910205
• MDR Text Key: 154873303
• Report Number: 2210968-2019-85803
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070224
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPLUGUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• 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: 79 YR