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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); Not Applicable (3189)
Event Date 11/02/2019
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. May we have a copy of operative notes from the initial surgery? the patient demographic info: age, weight, bmi at the time of index procedure? date of initial surgical procedure? other relevant patient history/concomitant medications and procedures? product code and lot number? onset of bowel and urinary dysfunction from the time of initial surgery? please specify urinary dysfunction? date, indication and surgical findings of mesh removal? was there any deficiency or anomaly of the mesh? if yes, please describe it what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status after mesh removal? were all symptoms resolved?.
 
Event Description
It was reported that the patient underwent a hysteropexy surgical procedure on unknown date and unknown mesh was implanted. It was reported that the patient experienced severe pelvic pain, walking difficulties/loss of mobility, loss of sexual function, severe bowel dysfunction, constipation and urinary dysfunction and underwent a midline laparotomy, removal of mesh. Additional information has been requested.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9522304
MDR Text Key189025288
Report Number2210968-2019-91341
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
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 Received12/05/2019
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

Patient Treatment Data
Date Received: 12/26/2019 Patient Sequence Number: 1
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