MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Injury (2348); Not Applicable (3189)

Event Date 02/16/2017

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.The patient demographic info: age, gender, weight, bmi at the time of index procedure.Name of index surgical procedure? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? describe medical/surgical intervention for exposure including dates.If reoperation: please provide the date.What were the findings on reoperation? were any deficiencies or anomalies noted with mesh device? are there any pictures available for evaluation? product code and lot #? if applicable, will product be returned, return date, tracking information what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2009 and the mesh was implanted.It has been noticed on (b)(6) 2017 by cystoscopy of one split urethral strip and trans-urethral passage.The urethra was torn on its right side by the strip.Ablation of the strip and suture of the urethra were performed.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4)2018.Patient code: (b)(4).Device code: (b)(4).Additional information requested and following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure:(b)(4).Name of index surgical procedure: unk the initial approach for the index surgical procedure? unk any concurrent procedure/device implantation? unk were there any intra-operative complications? unk describe medical/surgical intervention for exposure including dates: dissection of the strip if reoperation: please provide the date: (b)(4) 2017 what were the findings on reoperation? removal of the urinary catheter on (b)(4) 2017.Normal healing (no sign of inflammation, infection) were any deficiencies or anomalies noted with mesh device? evidence of intraurethral erosion of the strip at the right side of the urethra are there any pictures available for evaluation? no product code and lot # - not available what is the physician¿s opinion as to the etiology of or contributing factors to this event? unk what is the patient¿s current status? a big part of the sphincter is without lesion.No replacement of the implanted device.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7813261
• MDR Text Key: 118161019
• Report Number: 2210968-2018-75398
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2018
• 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: 62 YR
• Patient Weight: 63