UNKNOWN TISSUE EXPANDERS
Received Jul 11, 2018 · Event occurred Jun 15, 2018
Report 1645337-2018-04206 · MDR key 7680173
Device
Generic name
Expander, Skin, Inflatable
Manufacturer
Mentor TexasProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- No Code Available
- Unspecified Infection
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN UNKNOWN MENTOR TISSUE EXPANDER IMPLANTED AND GOT AN INFECTION. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2018.