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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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BOSTON SCIENTIFIC - MARLBOROUGH OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068505000
Device Problem Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an obtryx system device was used during an unknown procedure performed on an unknown date.According to the complainant, during unpacking of the device, it was noticed that the package was not sealed.The device was not used in a patient.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
 
Manufacturer Narrative
A visual examination of the returned obtryx system revealed that the tray was returned opened.There were uninterrupted witness marks along the entire edge of the tray confirming that the tray was sealed properly.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the reported issue was unable to be confirmed.
 
Event Description
It was reported to boston scientific corporation that an obtryx system device was used during an unknown procedure performed on an unknown date.According to the complainant, during unpacking of the device, it was noticed that the package was not sealed.The device was not used in a patient.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
 
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Brand Name
OBTRYX SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6844124
MDR Text Key84955464
Report Number3005099803-2017-02647
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729718987
UDI-Public(01)08714729718987(17)20200501(10)0000064333
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2020
Device Model NumberM0068505000
Device Catalogue Number850-500
Device Lot Number0000064333
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/16/2017
Initial Date FDA Received09/05/2017
Supplement Dates Manufacturer Received09/21/2017
Supplement Dates FDA Received10/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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