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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

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ETHICON INC. GYNECARE MESH UNKNOWN Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
It was reported that the patient underwent a gynecological procedure on an unknown date and a mesh was implanted.It was reported that following insertion the patient experienced pain, suffering and other losses arising from the defective product.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
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Brand Name
GYNECARE MESH UNKNOWN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
mary szaro
9082183464
MDR Report Key4891385
MDR Text Key6833657
Report Number2210968-2015-07841
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 06/15/2015
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 06/15/2015
Initial Date FDA Received07/06/2015
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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