DATACHOL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-21 for DATACHOL * manufactured by Ferndale Labs.

Event Text Entries

[497500] The nurse went into this patient's room at 2000 to draw blood. She briefly looked at the pt during the lab draw, and saw nothing remarkable at that time. At 2030 she turned the pt and noted the blanket was dampish. In process of removing the blanket, the pt was lifted and turned and nurse observed a skin breakdown which was 6cmx5cm in size, appeared to have had a blister that had broken, and was oozing yellow drainage. The area was cultured and then treated with silvadene cream. When the pt was turned, the nurse noted a clear cylinder that many of our products come in-this was not labeled. The cultures showed no growth and so we looked for other sources of a blister. In investigating this blister we found that the complete bed was changed of linen earlier on this day, had not been taken to any other area of the hospital and had no procedures done. After looking at what potential fluids could be in the vial, we concluded that it may have been detachol which may have been used when removing an et tube. I called the company that makes this product and a person from quality control stated that there have been several reported cases of burns/blistering when this product is left on the skin from newborn to adult. It generally occurred because it has been left on skin unknowingly-such as this case. He felt the box that contained the vials did explain this fact. Neither the peel pack which each vial is in, nor the box which was sent to the nursing unit had any warning that if left on the skin, it could cause potential burning/blistering. As of today, 7/19/06 the blistered area has completely healed. The pt is growing and will be going home by the end of the week. The night this incident occurred, the pt did become more ill, had to be re-intubated and received a full course of antibiotics. The neonatologist believes these incidents may have been related to the burn.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1039826
MDR Report Key751277
Date Received2006-07-21
Date of Report2006-07-21
Date of Event2006-06-12
Date Added to Maude2006-08-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDATACHOL
Generic NameADHESIVE REMOVER
Product CodeKOX
Date Received2006-07-21
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key739089
ManufacturerFERNDALE LABS
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-07-21

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