DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
Received May 4, 2015 · Event occurred Apr 14, 2015
Report 3003898360-2015-00342 · MDR key 4749206
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.
Additional Manufacturer Narrative
(B)(4). ONE (1) POUCH FROM P/N (B)(4) DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG WAS RECEIVED USED, OPENED, BUT IN ORIGINAL PACKAGING; PACKAGE CLOSED WITH TAPE AND A STAPLE, LOT # 01M1300356 WAS CONFIRMED WITH RECEIVED SAMPLES, DURING VISUAL INSPECTION WAS OBSERVED; SAMPLE WAS RECEIVED WITH 3 RUBBER BANDS INSIDE THE PACKAGE, RUBBER BANDS ARE BROKEN. SAMPLE RECEIVED CONFIRMS THE DEFECT REPORTED BY THE CUSTOMER DETERIORATED IN PACKAGE DURING VISUAL INSPECTION. ROOT CAUSE FOR THIS ISSUE IS CONSIDERED UNKNOWN DUE TO THE SAMPLE, WHICH WAS RECEIVED OPENED (MISSING 3 RUBBER BANDS). IN ADDITION 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." THIS DEFECT WAS FOUND BEFORE 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.
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.