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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.R. MEDICOM INC. (SHANGHAI) LTD. HENRY SCHEIN; COTTON ROLLS #2 NON STERILE
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A.R. MEDICOM INC. (SHANGHAI) LTD. HENRY SCHEIN; COTTON ROLLS #2 NON STERILE Back to Search Results
Catalog Number 102-5455
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Erosion (2075); Skin Erosion (2075); Skin Irritation (2076); Skin Irritation (2076); Tissue Breakdown (2681); Tissue Breakdown (2681)
Event Date 06/17/2015
Event Type  Injury  
Event Description
Two female patients had experienced blistering and redness immediately after a routine procedure.As a result both female pts were prescribed kenalog cream to help treat the blistering and redness.
 
Event Description
Two female patient had experienced blistering and redness immediately after a routine procedure.As a result both female pts were prescribed kenalog cream to help treat the blistering and redness.
 
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Brand Name
HENRY SCHEIN
Type of Device
COTTON ROLLS #2 NON STERILE
Manufacturer (Section D)
A.R. MEDICOM INC. (SHANGHAI) LTD.
938 xiang jing road
sonjang district, shanghai
CH 
MDR Report Key4924177
MDR Text Key18269297
Report Number2411236-2015-00005
Device Sequence Number1
Product Code EFN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Dentist
Type of Report Initial
Report Date 07/16/2015,06/17/2015
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received07/16/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number102-5455
Device Lot Number18636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2015
Distributor Facility Aware Date06/17/2015
Event Location Other
Date Report to Manufacturer07/14/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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