MalfunctionIWP
ESP
Received Nov 15, 2018 · Event occurred Oct 25, 2018
Report 2134265-2018-62840 · MDR key 8074273
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
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.