InjuryHRN
CRYOMATIC
Received Nov 6, 2015
Report 1000391004-2015-00001 · MDR key 5273434
Device
Product problems
- Difficult to Remove
- Device Operates Differently Than Expected
Patient
Not reported
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN EVALUATED AS IT WAS RETURNED TO THE MANUFACTURER ONLY TWO DAYS AGO. A FULL INVESTIGATION STARTED IMMEDIATELY UPON RECEIPT OF THE DEVICE, BUT NO RESULTS OF INVESTIGATION ARE AVAILABLE AS OF 10/28/2015. RESULTS OF INVESTIGATION WILL BE SUBMITTED IN THE SUPPLEMENTARY REPORT.
Description of Event or Problem
REFERENCE: (B)(4).
Remedial action
- Other