inforMED
MalfunctionBWN

TRENGUARD

Received Apr 26, 2019 · Event occurred Sep 28, 2018

Report 8554531 · MDR key 8554531

Device

Generic name

Table And Attachments, Operating-room

Manufacturer

Dan Allen Surgical

Catalog number

55201

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

16425 DA

  • Hair Loss
  • Head Injury
  • Headache
  • Hair Loss
  • Head Injury
  • Headache

Narrative

Description of Event or Problem

A PATIENT COMPLAINED OF A HEADACHE AFTER THEIR PROCEDURE AND HAD A BUMP ON HER HEAD. THE PATIENT WAS GIVEN AN ICE PACK TO PUT ON HER HEAD AND APPEARED TO BE OK. PATIENT WAS DISCHARGED HOME. PATIENT THEN CONTACTED HOSPITAL TO SAY SHE HAD DEVELOPED A SCAB ON THE TOP OF HER HEAD. ROUGHLY A WEEK AFTER THE PROCEDURE, PATIENT HAD MINIMAL HAIR LOSS AT THE TOP OF THE HEAD. THREE WEEKS AFTER THE PROCEDURE THE PATIENT DISPLAYED SIGNIFICANT HAIR LOSS AT THE TOP OF THE HEAD. AS OF LAST MONTH, THE PATIENT'S HAIR HAS NOT REGROWN.