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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; NONE
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SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; NONE Back to Search Results
Catalog Number UNK URETEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Injury (2348); Prolapse (2475); Osteopenia/ Osteoporosis (2651)
Event Date 11/29/2005
Event Type  Injury  
Event Description
According to the reporter: the patient alleged injury.Medical history: large cystocele, first degree uterine prolapse, diabetes, hypertension, hypercholesterolemia, osteopenia.
 
Manufacturer Narrative
(b)(4).Covidien is submitting this report on behalf of (b)(4) (importer).
 
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Brand Name
UNKNOWN URETEX MESH PRODUCT
Type of Device
NONE
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-01 600
FR  F-01600
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-01 600
FR   F-01600
Manufacturer Contact
sharon murphy
60 middletown ave.
north haven, CT 06473
2034925267
MDR Report Key3672103
MDR Text Key4341449
Report Number9615742-2014-00094
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2014
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK URETEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/24/2014
Initial Date FDA Received02/27/2014
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
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