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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 Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Date 09/21/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. To date it has been reported that the device will not be returned. If the device or further details are received at a later date a supplemental medwatch will be sent. (b)(4).
 
Event Description
It was reported that a patient underwent a sling procedure on an unknown date and mesh was implanted. The patient reported burning sensation in the hip, sensation of stretching in the stomach, inability to walk due to hip pain and inability to stand upright. No further information is available.
 
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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.
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12197481
MDR Text Key262482603
Report Number2210968-2021-06498
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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