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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 Migration (4003)
Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Discomfort (2330); Unspecified Tissue Injury (4559)
Event Date 01/20/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). No additional information is available. 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.  .
 
Event Description
It was reported that a patient underwent a gynecological procedure on (b)(6) 2021 and the mesh was implanted. It was reported that the mesh arms were visible from poor placement. It was also reported that there was interference with bladder and bowel and affected the pudendal nerve. It was also reported that it prevented intimacy due to pain. The patient had a general unwell feeling and took over the counter codeine and mersyndol until it was given only on doctors scripts. It was reported that the patient's next step was morphine¿ patches which had little benefit. It was reported that the patient was now on tapendol everyday with often adding quick release while pain is at its peak. The patient's surgeon commented on the patient's mental capacity. 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 Key11868369
MDR Text Key265975216
Report Number2210968-2021-04881
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received04/23/2021
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

Patient Treatment Data
Date Received: 05/22/2021 Patient Sequence Number: 1
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