FDA Adverse Event Injury Summary report: N

MASTISOL LIQUID ADHESIVE

MDR report key: 6878372 · Received September 20, 2017

Report

Report Number: 0001811212-2017-00002
Event Type: Injury
Date Received: September 20, 2017
Date of Event: July 11, 2017
Report Date: September 18, 2017
Manufacturer: FERNDALE LABORATORIES, INC.
Product Code: KGX
PMA / PMN Number: 510K EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT PROVIDED APPROVAL TO REACH OUT TO HER SURGEON REGARDING A LOT NUMBER OF THE MASTISOL, AND PROVIDED IMAGES OF HER REACTION VIA EMAIL. ON (B)(6) 2017 A MESSAGE WAS LEFT AT DOCTOR'S OFFICE WITH NURSE, AND NURSE RETURNED CALL AND LEFT MESSAGE TO CALL BACK AND LEAVE MESSAGE AT HER DIRECT LINE WITH FENDALE LABORATORIES, INC. EMAIL ADDRESS TO SEND PHOTOS OF THE MASTISOL LOT NUMBER USED. ON THE SAME DAY, A SECOND MESSAGE WAS LEFT FOR THE NURSE WITH FERNDALE LABORATOIES, INC. EMAIL ADDRESS AND INQUIRED ABOUT ANY ADDITIONAL DETAILS OF THE REACTION, THERE HAS BEEN NO RESPONSE BACK FROM DOCTOR'S OFFICE SINCE.

Description of Event or Problem · 1

A PATIENT CONTACTED FERNDALE LABORATORIES, INC. ON (B)(6) 2017 TO REPORT AN ADVERSE EVENT (ALLERGIC REACTION THAT CAUSED 2ND DEGREE BURNS/BLISTERS), ASSOCIATED WITH MASTISOL LIQUID ADHESIVE, LOT NUMBER UNKNOWN. PATIENT HAD CARPAL TUNNEL SURGERY ON (B)(6) 2017 AND EXPERIENCED AN ALLERGIC REACTION THAT CAUSED SEVERE BLISTERING AND SHE WAS DIAGNOSED WITH 2ND DEGREE BURNS. SHE WAS SEEN BY THE HOSPITAL BURN UNIT ON (B)(6) 2017 AND A DEBRIDEMENT PROCEDURE WAS PERFORMED ON THE AFFECTED AREA AS AN OUTPATIENT SURGERY. TO DATE, THE AFFECTED AREA IS HEALING; HOWEVER THE PATIENT IS STILL UNDER THE CARE OF THE DOCTORS HOSPITAL - (B)(6) BURN UNIT PHYSICIANS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
661047	MASTISOL LIQUID ADHESIVE	LIQUID ADHESIVE	KGX	FERNDALE LABORATORIES, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Other