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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON¿; MESH, SURGICAL, SYNTHETIC

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BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON¿; MESH, SURGICAL, SYNTHETIC Back to Search Results
Model Number M0068318200
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device is implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an upsylon¿ was used during a laparoscopic sacrocolpopexy procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient's prolapse returned.On mri it showed that the mesh got detached.The patient is scheduled for a surgery to patch the mesh together.Reportedly, there were no patient complications as a result of this event and the patient is fine.
 
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Brand Name
UPSYLON¿
Type of Device
MESH, SURGICAL, SYNTHETIC
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 Key6514904
MDR Text Key73450544
Report Number3005099803-2017-01183
Device Sequence Number1
Product Code OTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 03/29/2017
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 Model NumberM0068318200
Device Catalogue Number831-820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2017
Initial Date FDA Received04/23/2017
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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