MAUDE Adverse Event Report: ETHICON INC. VYPRO MESH; MESH, SURGICAL, POLYMERIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the adverse events described in the article? if yes, provide details of event and specific suture product code.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for ethicon devices used?.

Event Description

It was reported in a journal article that the patient underwent a laparoscopic inguinal hernia repair on unknown date between (b)(6) 2003 and (b)(6) 2006 and the mesh was implanted.It was possible that the patient experienced either hematoma, seroma or postoperative suction drain for intraoperative oozing.At one year after the procedure, the patient possibly experienced inguinal pain and it was either mild pain or moderate/severe disabling pain with numbness.The patient possibly experienced a decreased sperm motility.Additional information has been requested.

• Brand Name: VYPRO MESH
• 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: 6988584
• MDR Text Key: 90627455
• Report Number: 2210968-2017-70692
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K002672
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2017
• 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