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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH POLYFORM SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC

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BOSTON SCIENTIFIC - MARLBOROUGH POLYFORM SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number M0068402400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Inadequate Pain Relief (2388); Blood Loss (2597)
Event Type  Injury  
Event Description
As reported by the patient's attorney, a boston scientific device was implanted.According to the complainant, the patient experienced erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pain, operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue and nerve damage, the use of pain control and other mediations, injections into various areas of the pelvis spine and the vagina and operations to remove portions of the female genitalia.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand Name
POLYFORM SYNTHETIC MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
PROXY BIOMEDICAL LIMITED
coilleach spiddal
galway
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5245461
MDR Text Key31974733
Report Number3005099803-2015-03325
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial
Report Date 11/05/2015
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
Device Expiration Date10/31/2006
Device Model NumberM0068402400
Device Catalogue Number840-240
Device Lot NumberC000023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/05/2015
Initial Date FDA Received11/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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