TECATE DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Jul 15, 2011 · Event occurred May 17, 2011
Report 3003898360-2011-00320 · MDR key 2196559
Device
Product problems
- Material Separation
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. EVALUATION: METHOD: DEVICE HISTORY RECORD (DHR) REVIEW AND COMPLAINT HISTORY REVIEW PERFORMED. RESULTS: THE DHR REVIEW SHOWED THAT NO SIMILAR ISSUES WERE FOUND DURING THE MANUFACTURING OR PACKAGING PROCESSES OF THIS LOT. A COMPLAINT HISTORY WAS CONDUCTED ON THE REPORTED LOT NUMBER FROM (B)(6) 2010 TO (B)(6) 2011. NO SIMILAR DEFECT HAS BEEN REPORTED ON THIS CODE. CONCLUSIONS: (B)(4) WAS OPENED TO ADDRESS THE ISSUE. ROOT CAUSE - FAULTY COMPONENT USED. PER DEFECT DESCRIPTION IC CONCLUDED THAT BAND WAS DEFECTIVE. PER ANALYSIS MADE ON BANDS, COULD BE USED ON LOT REPORTED THAT HAD LOW LEVEL OF BHT. IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE CONCLUSION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem
THE EVENT IS REPORTED AS: COMPLAINT REPORTED AS: ELASTICS SEPARATED FROM HOOK. THIS TOOK PLACE DURING USE ON A PATIENT. PAPERWORK SUBMITTED BY HOSPITAL STATES THAT THERE WAS NO PATIENT HARM OR A CLOSE CALL.
Remedial action
- Other