DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PK
Received Jan 13, 2015 · Event occurred Dec 16, 2014
Report 3003898360-2015-00024 · MDR key 4421874
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME DUE TO THE LACK OF DEFECTIVE PRODUCT IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT AND TO DETERMINE THE ROOT CAUSE. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.
Description of Event or Problem
ALLEGED ISSUE: CUSTOMER CLAIMS BAND IN THE PACKAGING IS BROKEN AND UNUSABLE PRIOR TO OPENING PRODUCT. NO PATIENT INVOLVEMENT REPORTED.