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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW INC. OPSITE IV3000 DRESNG# 4007; TAPE AND BANDAGE, ADHESIVE
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SMITH & NEPHEW INC. OPSITE IV3000 DRESNG# 4007; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)
Patient Problems Reaction (2414); Skin Disorders (4543)
Event Type  Injury  
Event Description
Spontaneous call from pt reporting difficulty in using the tegadem, and iv3000 as they stick to his site when trying to remove dressing.Pt advised he tried using a "falsie" so that they wouldn't stick to site but was advised by rn at md office that creates an issue with sterility and that should not be used.Pt also purchased bandages from local pharmacy with adhesive just around the edges which has been working.Author advised we have primapore and mepilex dressings which do not have adhesive in the middle.Pt advised he thinks he may have tried primapore and had a reaction to the adhesive.Pt added he was unable to use the smaller primapore and still has larger primapore if he would have to use those.Author suggested he try the mepilex dressing since it does not have adhesive in the middle of the bandage.Pt reported he still has sores from reaction to adhesive at his previous site.No other information or dates available.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
OPSITE IV3000 DRESNG# 4007
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
SMITH & NEPHEW INC.
MDR Report Key10852104
MDR Text Key216920352
Report NumberMW5097929
Device Sequence Number1
Product Code KGX
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/12/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/16/2020
Patient Sequence Number1
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