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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Pain (1994); Seroma (2069); Skin Discoloration (2074); Urinary Retention (2119); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 12/14/2017.(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 bilateral inguinal hernia repair/ lichtenstein hernioplasty procedure on unknown date between 2009 and 2012 and the mesh was implanted on both sides.The patient possibly experienced postoperative mild, moderate or severe pain, which was controlled by nonsteroidal anti-inflammatory drugs, diclofenac sodium 75mg im injection.It was possible that the patient experienced complications, include urine retention treated with catheterization, mild scrotal edema resolved spontaneously, superficial ecchymosis of the wound treated conservatively, unilateral seroma, numbness at the upper medial side of the thigh and/or feeling of foreign body.It was also reported that for postoperative pain, the patient possibly had intermittent pain that lasted for six months not interfering with activities or for up to 9 months not interfering with activities.Postoperative complications disappeared at the end of the follow-up period with no recurrence.Additional information has been requested.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• 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: 7119298
• MDR Text Key: 94928828
• Report Number: 2210968-2017-71804
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• 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: 10/24/2017

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: 10/24/2017
• Initial Date FDA Received: 12/14/2017
• 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