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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC; DRESSING,WOUND,OCCLUSIVE
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CONVATEC DOMINICAN REPUBLIC INC; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
Device Problem Nonstandard Device (1420)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
 
Event Description
It was reported "the dressing was less absorption." the dressings were used on either the face or the leg/hand.The dressings were in place for one day.No harm was reported.It was unknown the number of dressings used.Follow up information was requested for the exact location and it could not be confirmed by the reporter.No photographs were provided.
 
Event Description
It was reported "the dressing was less absorption." the dressings were used on either the face or the leg/hand.The dressings were in place for one day.No harm was reported.It was unknown the number of dressings used.Follow up information was requested for the exact location and it could not be confirmed by the reporter.No photographs were provided.
 
Manufacturer Narrative
D.1: duoderm/granuflex/duoactive - moisture retentive duoderm cgf dressing no lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional information was requested but, no additional information could be provided.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Manufacturing site: 9618003.
 
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Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
MDR Report Key10245883
MDR Text Key198698397
Report Number9618003-2020-12210
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 distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberWOUND CARE-UNKNOWN SURGICAL COVER DRESSI
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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