FDA.reportPublic FDA data

MAUDE MDR 3381076

MDR report key
3381076
Report number
2243969-2013-00104
Event key
0
Event type
3
Date of event
2013-08-13
Date received
2013-09-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MARY SZARO, ASSOC DIRECTOR
Address
200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US
Phone
908-908-9089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAF-GEL - WOUND DRESSING W/ ALGINATEHYDROGEL WOUND AND BURN DRESSINGACCUPAC, INCNAE1457301457301952A3R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-3001. R

Event Narratives#

D

Patient 1

THE PT WAS SEEN AT (B)(6) MEDICAL CARE ON (B)(6) 2013, FOR AN ULCER ON THEIR LEFT LOWER LEG (DIAMETER 6X6 CM AND 0.5 CM DEEP). THE WOUND WAS REPORTEDLY 90% DRY FIBRIN TISSUE AND 10% GRANULATION TISSUE. THE SURROUNDING SKIN HAD SIGNS OF ERYTHEMA, SCALING, AND HEAT EXTENDING TO THE LOWER PORTION OF THE LIMB. ON THE INSIDE PORTION OF THE RIGHT LOWER LEG IT WAS REPORTED ALL OF THE SKIN HAD EDEMA, ERYTHEMA, REDNESS, FLAKING, AND SLOUGH. A PEDAL PULSE WAS PRESENT. THE PT WAS TREATED WITH DUODERM GCF ON THE ULCER (LEFT LEG) SAF-GEL AND FLEXIDRESS ON BOTH LOWER LEGS. THE SAME DRESSINGS WERE RE-APPLIED ON (B)(6) 2013. ON (B)(6) 2013, THE PT HAD AN INCREASE IN EDEMA IN THE LOWER RIGHT LEG ALONG WITH HEAT, REDNESS,SWELLING, RASH, AND SLOUGH (DIAMETER OF 20X20 CM). ON THE LOWER LEFT LEG THE ULCER WAS STILL PRESENT (5X4 CM) ALONG WITH FIBRINOID TISSUE DECREASE, INCREASED ERYTHEMA, PAIN, EDEMA, AND ITCHING SO THE FLEXIDRESS AND SAF-GEL WERE DISCONTINUED. THE PT ALSO HAD REDNESS, SWELLING AND ITCHING ON THEIR FACE AND ARMS. BOTH OF THE PT'S WOUNDS WERE REDRESSED WITH PETROLEUM JELLY AND GAUZE AND THE PT WAS TOLD TO GO TO THE EMERGENCY ROOM FOR A MEDICAL EVALUATION. ON (B)(6) 2013, THE PT SAW A DOCTOR AND THEY WERE TOLD THEY WERE HAVING AN ALLERGIC REACTION TO FLUNARIZINE WHICH THEY TOOK ON (B)(6) 2013. THE PT WAS TAKEN OFF OF THE FLUNARIZINE AND STARTED TAKING CEPHALEXIN 500MG EVERY 6 HOURS FOR 10 DAYS ALONG WITH IBUPROFEN. ON (B)(6) 2013, IT WAS REPORTED THE PT STATED THEY BEGAN TAKING CEPHALEXIN AND THE IBUPROFEN AND HAD A DECREASE IN INFLAMMATION AND RASH (INCLUDING ON THEIR HANDS AND FACE). ON (B)(6) 2013, THE PT WAS RESTARTED ON THE FLEXIDRESS, SAF-GEL, AND DUODERM CGF ON LOWER LEFT LEG AND AQUACEL (15X15 CM) AND FLEXIDRESS ON THE RIGHT LEG. THE PT RECEIVED TWO ADDITIONAL TREATMENTS ON (B)(6) 2013. ON (B)(6) 2013, THE PT RETURNED TO (B)(6) MEDICAL CARE AND STATED THEY WERE EXPERIENCING PAIN, HEAT, AND REDNESS. THE PT'S LEGS WERE TREATED WITH VASELINE AND COVERED WITH GAUZE. THE ULCER ON THE LEFT LEG WAS TREATED WITH DUODERM CGF AND GEL.

N

Patient 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. THE PT WAS REFERRED BACK TO THE DOCTOR ON (B)(6) 2013. QUALITY RECORDS WERE REVIEWED BY THE THIRD PARTY MANUFACTURER AND NO NON-CONFORMANCES WERE IDENTIFIED. A BATCH RECORD REVIEW FOUND ALL ITEMS CORRECT AND NO IRREGULARITIES IN PRODUCTION. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE SAF-GEL WOUND DRESSING W/ ALGINATE AND THIS EVENT IS DEEMED PROBABLE BECAUSE PRODUCT USE IS TEMPORARILY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. (B)(4). THIRD PARTY MFR: (B)(4).