NEUTRA SKIN * 7OS2432

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-11 for NEUTRA SKIN * 7OS2432 manufactured by Incutech Partners.

Event Text Entries

[3728229] Extremely premature infant with multiple necrotic lesions on face, extremities, and trunk that initially appeared 4 days post delivery. Infant was born via vaginal delivery to a g1p1 mom whose pregnancy was complicated by ptl (pre-term labor). She had received steroids and 9 doses of penicillin ptd (prior to delivery). Apgars were 4/6/8. Infant was intubated at birth and given curosurf. At birth was started on amp/gent and fluconazole prophylaxis. Uac/uvc (umbilical arterial catheter/umbilical venous catheter) were placed. Extubated to hfnc dol 1 (high flow nasal cannula day of life 1). Patient developed large pda (patent ductus arteriosus) on day 2 of life that was treated with single dose of indocin. Ampicillin was changed to vancomycin on day 2 of life. He developed grade iii ivh (intraventricular hemorrhage) and perforation of duodenum at day 2 of life. He was re-intubated on day 2 of life. Exploratory lap on day 2 of life. Jejunostomy and mucous fistula. Broviac placed on day 3 of life. On day 4 of life, nursing noted dark lesion on chin. This lesion rapidly enlarged and additional sites subsequently developed on the abdomen, legs and arms. Infection disease (id) physician consulted. Id recommended obtaining fungal cultures of skin lesions and blood and starting amphotericin b and merrem. Fungal cultures positive for rhizopus and bipolaris. At the time these lesions developed the infant had severe acidosis and was on epinephrine and vasopressin. He also had been neutropenic at birth. Staff noted that the initial darkened area occurred on the chin where a skin barrier product was in use. On examining the skin barrier product (opened and unopened) kept at the patient's bedside, an intermittent dark grey/black discoloration was noted along the outer border of the product which raised a concern regarding possible contamination. Product was removed from the bedside and submitted to the lab for testing. When additional unopened product was examined, the same discoloration was noted. As a precaution, a decision was made to remove all product within our system from use until the results of the testing are known. Results expected within ~ 4 weeks. We contacted the manufacturer and notified them of our concern about a possible contaminant. They mentioned that the discoloration may be related to the tool they use to cut their product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3345752
MDR Report Key3345752
Date Received2013-09-11
Date of Report2013-09-11
Date of Event2013-09-06
Report Date2013-09-11
Date Added to Maude2013-09-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameNEUTRA SKIN
Generic NameSKIN BARRIER
Product CodeFON
Date Received2013-09-11
Model Number*
Catalog Number7OS2432
Lot Number25530.001
ID Number*
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerINCUTECH PARTNERS
Manufacturer Address200 KELLY DR. SUITE A PEACHTREE CITY GA 30269 US 30269

Device Sequence Number: 2

Brand NameNEUTRA SKIN
Generic NameSKIN BARRIER
Product CodeFON
Date Received2013-09-11
Model Number*
Catalog Number7OS2432
Lot Number24221.001
ID Number*
Device AvailabilityY
Device Age*
Device Sequence No2
Device Event Key0
ManufacturerINCUTECH PARTNERS
Manufacturer Address200 KELLY DR. SUITE A PEACHTREE CITY GA 30269 US 30269

Device Sequence Number: 3

Brand NameNEUTRA SKIN
Generic NameSKIN BARRIER
Product CodeFON
Date Received2013-09-11
Model Number*
Catalog Number7OS2432
Lot Number34331.00
ID Number*
Device AvailabilityY
Device Age*
Device Sequence No3
Device Event Key0
ManufacturerINCUTECH PARTNERS
Manufacturer Address200 KELLY DR. SUITE A PEACHTREE CITY GA 30269 US 30269


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2013-09-11

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