CONVATEC * 401906

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-07 for CONVATEC * 401906 manufactured by E.r. Squibb And Sons.

Event Text Entries

[274953] Reporter is writing to express their concern about use of the convatec sur-fit natura stomadhesive wafer ostomy appliances at their hosp. This is product #401906. These appliances are a danger to pts because of their inferior design and poor quality. They do not adhere to the skin even when applied carefully. In april reporter performed a colostomy on a pt and was given the convatec two-piece ostomy appliance. After cleaning the skin and applying benzoin they applied the wafer and within minutes they could visibly see the wafer lifting off the skin. Fortunately the nurse was able to find one of the few remaining hollister appliances; reporter removed the convatec wafer, reapplied the hollister wafer with no further difficulty. In a different situation, a pt with an ileostomy had extensive skin excoriation, which was the result of multiple changes of their convatec ileostomy appliance. This pt had between 10 and 12 applications and reapplications of their ileostomy appliance because of this inadequate device. The nursing staff of the surgical unit have also reported their concerns and difficulties with this appliance to the director of nursing on numerous occasions. To date the hosp administration as refused to rectify the situation by eliminating the convatec appliances and returning to the use of the hollister device, which has always been the gold standard for this type of product. Reporter expressed their grave concerns personally to the convatec sales representative at the hosp. She stated that there were two different convatec ostomy products available and that the purchasing department of the hosp chose to purchase the cheaper and more inferior of the two products. She then stated that other physicians had voiced similar concerns about that product to her. Even if cost is a consideration, clearly this inferior product should not be in use. The risk of stool spillage into a new surgical incision is significant, the cost of wound infection is great. The cost of frequent nursing care in cleaning soiled pts and frequent changing of appliances should be factored in. Skin maceration and cellulites are the end result of poorly fitting and leaking ostomy appliances. Please investigate and have this inferior product removed from the market.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1028942
MDR Report Key471079
Date Received2003-07-07
Date of Report2003-07-07
Date of Event2003-06-29
Date Added to Maude2003-07-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCONVATEC
Generic NameSUR-FIT NATURA STOMADHESIVE WAFER OSTOMY APPLIANCES
Product CodeEZS
Date Received2003-07-07
Model Number*
Catalog Number401906
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key459919
ManufacturerE.R. SQUIBB AND SONS
Manufacturer Address* PRINCETON NJ 08543 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2003-07-07

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