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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC

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CONVATEC DOMINICAN REPUBLIC INC Back to Search Results
Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Increased Sensitivity (2065); Skin Inflammation (2443)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via the end user who is a surgical assistant that he had a right knee arthroscopy revision on (b)(6) 2019. When he removed the dressing on (b)(6) 2019, he had "extreme redness, almost blistering under the hydrocolloid portion of the dressing". Clarified that the taffy pull technique was used to remove the dressing. Clarified that no actual blisters were present. End user states at "4 weeks post-op, he can still see the imprint from the dressing on his skin, still has some raised areas and he still has itching. However, he reports that is experiencing itching all over his body and still has redness from his ankle up on the right leg. " patient advised that no prescriptions or medical treatment were provided. He self-treated with over the counter oral benadryl, oral gabapentin (prescribed for a different event) and topical triamcinolone 0. 1 (prescribed for a different event). He is not completely sure about the pre-op prep but he has worked with this surgeon in the past and the typical prep is a chlorhexidine bath prior to surgery which he did complete, alcohol prep of the entire limb, betadine paint prep of the site followed by chlorhexidine paint and then ioban drape. He was alert for the surgery, only having a spinal block. He does not believe that this was cleansed away prior to the dressing application. He advised that the knee was flexed to 30-35 degrees for dressing application. ".
 
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Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9536179
MDR Text Key187696683
Report Number1049092-2019-00248
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberWOUND CARE-UNKNOWN SURGICAL COVER DRESSI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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