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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.If in your possession, may we have a copy of your operative report(s)? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon's name, contact information and sign release of medical information form attached.  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events associated with patient's hernia repair reported via mw # 2210968-2021-03014.

Event Description

It was reported that a patient underwent a pelvic surgery on an unknown date in 2010 and the mesh was implanted.It was reported that the patient began having issues a couple days after the surgery in 2010.It was reported that since the surgery the patient has routine blood transfusions ranging from a week to three weeks.It is also reported that the patient had multiple infections.It was reported that the patient was hospitalized for c diff as a result of the number of antibiotics taken.The patient has seen multiple physicians who won't perform removal surgery.It was reported that during a pap a physician noticed that the patient's bladder had been turned around.It was reported that the patient has had issues urinating and holding urine.It was also reported that at this time the patient does not have an infection and the device is implanted.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 4/30/2021.Additional information was requested and the following was obtained: if in your possession, may we have a copy of your operative report(s)? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon's name, contact information and sign release of medical information form attached.Signed copy of patient authorization form has been received.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.Please provide your surgeon's name, contact information so ethicon can obtain more clinical information to be used for a product quality complaint investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 01/13/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional b5 narrative: patient called back, patient has been going back to receive blood transfusions every month to two months and sometimes.Patient is become tired of receiving the transfusions.Patient is still having the pain.Patient can't do anything.Patient is hurting all the time.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11611778
• MDR Text Key: 251800237
• Report Number: 2210968-2021-03013
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

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?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/03/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 12/15/2021
• Supplement Dates FDA Received: 04/30/2021; 01/13/2022
• 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 Sex: Female