CAPIO RP SUTURING DEVICE 832-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-22 for CAPIO RP SUTURING DEVICE 832-101 manufactured by Boston Scientific - Miami.

Event Text Entries

[454027] A pt underwent a radical prostatectomy procedure in 2003. After the procedure was successfully completed internal bleeding occurred. Pt was treated for blood loss and internal bleeding. Physician irrigated clots out. No other info is available.
Patient Sequence No: 1, Text Type: D, B5


[7845837] The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and co is not able to determine if the device met specification.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000111-2006-00020
MDR Report Key728347
Report Source05,06
Date Received2006-06-22
Date of Report2004-01-21
Date of Event2003-11-03
Date Mfgr Received2004-01-27
Date Added to Maude2006-06-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactNANCY CUTINO
Manufacturer StreetONE BOSTON SCIENTIFIC PLACE
Manufacturer CityNATICK MA 01760
Manufacturer CountryUS
Manufacturer Postal01760
Manufacturer Phone5086834066
Manufacturer G1BOSTON SCIENTIFIC - MIAMI
Manufacturer Street8600 N.W. 41ST STREET
Manufacturer CityMIAMI FL 33166620
Manufacturer CountryUS
Manufacturer Postal Code33166 6202
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPIO RP SUTURING DEVICE
Generic NameSUTURE CAPTURING DEVICE
Product CodeMCZ
Date Received2006-06-22
Model NumberNA
Catalog Number832-101
Lot NumberUNK
ID NumberNA
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key716643
ManufacturerBOSTON SCIENTIFIC - MIAMI
Manufacturer Address8600 N.W. 41ST ST MIAMI FL 331666202 US
Baseline Brand NameCAPIO RP
Baseline Generic NameSUTURING SYSTEM
Baseline Model No*
Baseline Catalog No832-101
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-06-22

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