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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND* PROPEN TOPICAL SKIN ADHESIVE; ADHESIVE, TOPICAL SKIN

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ETHICON INC. DERMABOND* PROPEN TOPICAL SKIN ADHESIVE; ADHESIVE, TOPICAL SKIN Back to Search Results
Catalog Number APPXL6
Device Problem Reaction (1514)
Patient Problem Reaction (2414)
Event Date 04/29/2014
Event Type  Injury  
Event Description
It was reported that a patient underwent a surgical procedure on an unknown date and topical skin adhesive was used.At the post-op follow up, the patient had urticaria/hives.The surface was bumpy and the patient felt itchy on the wound where the adhesive was applied.Additional information has been requested.
 
Manufacturer Narrative
(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
Manufacturer Narrative
Upon review of new information, no medical or surgical intervention was performed.This report does not meet serious injury reportability criteria and will be voided.
 
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Type of Device
ADHESIVE, TOPICAL SKIN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 0075 4
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key3824882
MDR Text Key4503271
Report Number2210968-2014-06450
Device Sequence Number1
Product Code MPN
Combination Product (y/n)N
Reporter Country CodeKN
PMA/PMN Number
K100423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberAPPXL6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/06/2014
Initial Date FDA Received05/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/18/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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