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

Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)

Patient Problems Obstruction/Occlusion (2422); Not Applicable (3189)

Event Date 06/13/2018

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure.The initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? what were current symptoms following the index surgical procedure? onset date? are there any pictures available for evaluation? other relevant patient history/concomitant medications.Product code and lot #.What is physician¿s opinion as to the etiology of or contributing factors to this event.What is the patient current status?.

Event Description

It was reported that the patient underwent laparoscopic hysteropexy on (b)(6) 2017 and mesh was implanted.It was reported that the procedure was uneventful and mesh was all buried extraperitoneally.The patient had a good outcome and was discharged from clinic at follow-up on (b)(6) 2018.The patient presented with small bowel obstruction under general surgeons on (b)(6) 2018.Laparotomy on (b)(6) 2018 found necrotic small bowel loop stuck under a loop of mesh behind uterus which had come away from pelvic side wall and entrapped the loop.Small bowel resection was performed and all visible mesh removed.It was reported that patient has uneventful recovery but prolapse has now returned.The patient is awaiting gynaecological follow up.Additional information has been requested.

• Brand Name: GYNECARE 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.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7855134
• MDR Text Key: 119531702
• Report Number: 2210968-2018-75693
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/07/2018
• 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