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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DERMA SCIENCES, INC. DUTEX COTTON 2 PLY CONFORMING BAND - 2" X 4.1 YDS ISLAND AND COMPOSITE DRESSINGS

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DERMA SCIENCES, INC. DUTEX COTTON 2 PLY CONFORMING BAND - 2" X 4.1 YDS ISLAND AND COMPOSITE DRESSINGS Back to Search Results
Catalog Number 77781
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
It was reported that after product was soaked in sterile water, product is slimy and falls apart leaving pieces in the wound. This is going to delay the recovery process. No patient injury reported.
 
Manufacturer Narrative
Investigation completed on 03/06/2018. Device history record cannot be reviewed for product 77781 lot number was not provided. Root cause cannot be determined as no samples were returned for evaluation. We did not confirm the issue on the retained sample. Complaint trend was reviewed for the past 2 years and did not receive similar complaints on this product code, lot and this matter. The complaint was forwarded to our vendor for full investigation. As per vendor investigation, no samples were returned for evaluation, no lot number was available and root cause cannot be determined. Vendor had similar testing as per customer¿s description. Vendor had conducted a shake test on the sponge and after the testing, there was small amount of lint fallen off from the sponge which is consider acceptable. Vendor then conducted a soaking test with normal saline to observe for oil and/or slimy situation as per complaint narrative. There was no residuals, oil or slimy situation was noted on the saline solution and the gauze sponge did not break apart. Based on the test results that the vendor collected, the product is conforming its intended use.
 
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Brand NameDUTEX COTTON 2 PLY CONFORMING BAND - 2" X 4.1 YDS
Type of DeviceISLAND AND COMPOSITE DRESSINGS
Manufacturer (Section D)
DERMA SCIENCES, INC.
104 shorting road
104 shorting road
toronto, ontario M1S 3 S4
CA M1S 3S4
Manufacturer (Section G)
DERMA SCIENCES, INC.
104 shorting road
toronto, ontario M1S 3 S4
CA M1S 3S4
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7314308
MDR Text Key101845062
Report Number9680091-2018-00011
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number77781
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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