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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH

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ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Catalog Number CLR422
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested and obtained. What does the traction burns look like and how large of an area does the reaction cover? 2 areas 2x10 cm. Do you have any pictures of the traction burns? yes unable to send without patient approval. Was there any medical or surgical intervention performed to treat the traction burns (re-operation; re-closure; prescription steroids; antibiotics prescribed; other medication prescribed)? if so, please clarify. Surgically debrided - began dressing changes and bacitracin. What is the most current patient status? was healing at last visit. Can you identify the lot number of the product that was used? no. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no - other side applied with same setting no difficulty. Additional information was requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Please attempt to receive approval from the patient to share photos with us. Please describe how the adhesive was applied. What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie. Allergies, history of reactions) has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no product available for return.
 
Event Description
It was reported a patient underwent a buttock lift procedure on (b)(6) 2021 and topical skin adhesive was used. Post-op, on (b)(6) 2021 patient presented with traction burns. Area was surgically debrided, began dressing changes and treated with bacitracin. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11739537
MDR Text Key262524878
Report Number2210968-2021-03921
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR422
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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