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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ESP¿ GLOVE, PATIENT EXAMINATION, SPECIALTY

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ESP¿ GLOVE, PATIENT EXAMINATION, SPECIALTY Back to Search Results
Model Number M001201131
Device Problem Hole In Material (1293)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
During preparation while the physician was putting his fingers in the esp¿ gloves, a hole was noticed. A new pair of gloves was used to complete the case.
 
Manufacturer Narrative
Device evaluated by mfr: received one pair of size 8 gloves with its original envelope. No visible residue was found on the gloves. A visual examination of the gloves found the left glove to be without issue. The mating right glove presented a tear at the fold located in the thumb. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is considered handling damage as the event occurred prior to patient contact. (b)(4).
 
Event Description
During preparation while the physician was putting his fingers in the esp¿ gloves, a hole was noticed. A new pair of gloves was used to complete the case.
 
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Brand NameESP¿
Type of DeviceGLOVE, PATIENT EXAMINATION, SPECIALTY
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6407656
MDR Text Key70063165
Report Number2134265-2017-02265
Device Sequence Number1
Product Code LZC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K891968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM001201131
Device Catalogue Number20-113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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