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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DERMA SCIENCES, INC. SUTURE STRIP PLUS, 1/4" X 4"; WOUND CLOSURES
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DERMA SCIENCES, INC. SUTURE STRIP PLUS, 1/4" X 4"; WOUND CLOSURES Back to Search Results
Catalog Number TP1102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Tears (2516); Skin Inflammation/ Irritation (4545)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
Product sample was not returned for evaluation; however, pictures were provided and evaluated.Dhr - no anomalies.Failure mode is confirmed.Root cause is undetermined.The potential/possible root cause is that the practitioner may have forced to remove the strip from the skin and caused the skin tear.
 
Event Description
6 of 8 reports.Other mfg report numbers: 9680091-2021-00017, 9680091-2021-00018, 9680091-2021-00019, 9680091-2021-00020, 9680091-2021-00021, 9680091-2021-00022, 9680091-2021-00024.A facility reported patients treated with suture strip suffer from skin tears and skin irritation.No patient consequences.No additional information has been received.
 
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Brand Name
SUTURE STRIP PLUS, 1/4" X 4"
Type of Device
WOUND CLOSURES
Manufacturer (Section D)
DERMA SCIENCES, INC.
104 shorting road
104 shorting road
toronto, ontario M1S 3 S4
CA  M1S 3S4
MDR Report Key12729556
MDR Text Key279345204
Report Number9680091-2021-00023
Device Sequence Number1
Product Code FPX
Combination Product (y/n)N
PMA/PMN Number
K894205
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberTP1102
Device Lot NumberB20103
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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