DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
Received May 4, 2015 · Event occurred Apr 14, 2015
Report 3003898360-2015-00341 · MDR key 4749220
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT ALLEGES THAT PRODUCT IS DETERIORATING IN PACKAGING. ELASTICS ARE CRACKING AND BREAKING. FOUND PRIOR TO USE ON PATIENT DURING INSPECTION/FUNCTIONALITY TESTING. NO PATIENT INJURY REPORTED.
Description of Event or Problem
COMPLAINT ALLEGES THAT PRODUCT IS DETERIORATING IN PACKAGING. ELASTICS ARE CRACKING AND BREAKING. FOUND PRIOR TO USE ON PATIENT DURING INSPECTION/FUNCTIONALITY TESTING. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
(B)(4). ONE (1) POUCH FROM P/N (B)(4) DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG WERE RECEIVED NOT USED, CLOSED IN ORIGINAL PACKAGING, LOT # 01B1400382 WAS CONFIRMED WITH RECEIVED SAMPLES, DURING VISUAL INSPECTION IT WAS OBSERVED; RUBBER BANDS ARE BROKEN. FAILURE MODE DETERIORATED IN PACKAGE REPORTED BY THE CUSTOMER WAS CONFIRMED DURING VISUAL INSPECTION. SAMPLE RECEIVED SHOWS CONFIRM THE DEFECT REPORTED BY THE CUSTOMER DETERIORATED IN PACKAGE. A REVIEW WAS CONDUCTED OF THE IFU AND IT WAS FOUND THE CUSTOMER IS DIRECTED TO "INSPECT EACH DURAHOOK AND DERMAHOOK PRIOR TO USE, SPECIFICALLY TO ENSURE THE INTEGRITY OF THE ELASTIC BAND. IF THE ELASTIC BAND CONTAINS TEARS, SPLITS OR OTHER DAMAGE, DO NOT USE." IN ADDITION, THIS DEFECT WAS FOUND BEFORE TO USE ON PATIENT. THEREFORE, A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. HOWEVER WE WILL CONTINUE TO MONITOR TRENDING OF SIMILAR COMPLAINTS.
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.