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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
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.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, 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 Key11611778
MDR Text Key251800237
Report Number2210968-2021-03013
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
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
Date FDA Received04/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/03/2021 Patient Sequence Number: 1
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