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

Model Number M001201101

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

I was reported that when using the esp¿ specialty gloves, the physician would have to use multiple pairs during a procedure due to tearing at the seams.No patient or provider complications were reported to be related to this event.

• Brand Name: ESP¿
• Type of Device: GLOVE, 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 Key: 7495668
• MDR Text Key: 107636354
• Report Number: 2134265-2018-03840
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001201101
• Device Catalogue Number: 20-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1