MAUDE Adverse Event Report: ETHICON INC. UNK_ULTRAPRO HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC

Device Problem Leak/Splash (1354)

Patient Problem Edema (1820)

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.Additional information was requested and the following was obtained: indicate the procedure the mesh was used in, what was the indication for use? repair for the inguinal hernia.Provide a specific product code and lot number? ultrapro hernia system was used in this report.The product code and lot number was unknown.Were the experiences reported pre-existing conditions, it is noted that the patient had a diagnosis of cirrhosis of the liver? yes.In this event a treatment ie medication tolvaptan is noted please indicate if the patient required any surgical intervention.The drain was placed for the leakage.How is the patient doing at this time? the patient was recovered and discharged.

Event Description

It was reported in journal abstract ¿a case of ascites leakage after the operation on communicating hydrocele with intractable ascites successfully treated with tolvaptan.¿, hirotaka hamada, daisuke matushita, fumitake kubo, hidetoshi noma, kozo takahashi, syouji natugoe that a patient with marked liver cirrhosis associated intractable ascites was admitted for the treatment of communicating hydrocele in 2016.The administration of tolvaptan led a decrease ascites before the operation.The patient underwent repair for an inguinal hernia and mesh was implanted.Lower abdomen and scrotum edema was caused by ascites leakage after operation.Tolvaptan was administered again to reduce edema on postoperative day 6.Edema was significantly improved in 3 days.Ascites leakage from surgical wound was persistent after that.A closed drain was placed under surgical wound and patient was administered tolvaptan for 25 days continuously to improve the ascites leakage.The patient recovered and was discharged.No additional information was provided.

• Brand Name: UNK_ULTRAPRO HERNIA SYSTEM
• 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 GMBH; p.o. box 1409 d22841; norderstedt
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7299245
• MDR Text Key: 101057288
• Report Number: 2210968-2018-71064
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/27/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR