AVALON CL FETAL & MATERNAL PATCH

Description of Event or Problem

IT WAS REPORTED THE PATIENT DEVELOPED A TISSUE INJURY OR SKIN TEAR FROM THE FETAL MONITORING POD, SO THE POD WAS REMOVED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

Additional Manufacturer Narrative

A GOOD FAITH EFFORT (GFE) WAS MADE TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED ISSUE AND IN RESPONSE IT WAS INDICATED THAT THERE WAS NO PICTURES OF THE INJURY WERE AVAILABLE. THE AREA OF INJURY WAS ON THE LOWER ABDOMEN, APPROXIMATELY 1.1CM IN SIZE WITH SUPERFICIAL SKIN LOSS CONSISTING OF DRY SKIN. THE INJURY WAS IN THE SHAPE OF THE HUB OF THE POD. THE PATIENT'S SKIN IS BEING ASSESSED DAILY BUT NO INTERVENTION WAS REQUIRED, AND THE INJURY WAS EXPECTED TO HEAL COMPLETELY. BASED ON THIS INFORMATION, THE REPORTED TRAUMA TO THE PATIENT'S SKIN DOES NOT MEET THE CRITERIA FOR SERIOUS INJURY. THE CUSTOMER CONFIRMED THAT THE AVALON CL FETAL & MATERNAL PATCH WAS NOT CHECKED. THE PATCH WAS REMOVED BY THE MIDWIFE WHEN THE SKIN INJURY WAS OBSERVED AND THROWN AWAY BECAUSE IT WAS DISPOSABLE. THE CUSTOMER ALSO CONFIRMED THAT THERE WAS NO FAULT OBSERVED IN THE DEVICE AND THE DEVICE WAS WORKING AS INTENDED. THE ALLEGATION WAS AGAINST THE PATCH AND NOT THE DEVICE. THE PATCH WAS NOT AVAILABLEFROM CUSTOMER SO NO EVALUATION COULD BE DONE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED.

Additional Manufacturer Narrative

PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT DEVELOPED A TISSUE INJURY OR SKIN TEAR FROM THE FETAL MONITORING POD, SO THE POD WAS REMOVED. THE DEVICE WAS IN CLINICAL USE, PATIENT INVOLVEMENT WAS REPORTED.