MalfunctionIWP
ESP
Received Nov 16, 2018 · Event occurred Oct 1, 2018
Report 2134265-2018-62841 · MDR key 8080099
Device
Generic name
Glove, Patient Examination, Specialty
Manufacturer
Boston Scientific CorporationModel number
37415Catalog number
37415
Lot number
0020986742
Product problems
- Defective Device
- Defective Device
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
EVENT DATE: THE EVENT DATE WAS NOT REPORTED; THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS SELECTED AS AN ESTIMATE.
Description of Event or Problem
IT WAS REPORTED THAT SEVERAL PAIRS OF SIZE 8 ESP SPECIALTY GLOVES HAD BEEN OPENED AND EVERY PAIR HAD A HOLE IN THE WRIST. THERE WERE NO PATIENT OR PHYSICIAN INJURIES OR ISSUES REPORTED TO HAVE OCCURRED.