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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Skin Irritation (2076); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint # pc-(b)(4). Additional patient codes: (b)(6) ¿ infection; (b)(6) ¿ wound secretion; (b)(6)¿ blistering; (b)(6) skin discoloration. Representative samples were received for evaluation. The samples were tested for purity, functionality and set time and temperature. All analysis demonstrate the prineo lots tested ldh420, lbh800, and lhh607 meet the criteria for purity and device functionality and setting time and setting temperature. Additional information was requested and the following was obtained: procedure: mastopexy patient experienced symptoms of red, weeping welts, blistering, infection at 3-4 weeks post op, possible systemic reaction on arms and face, or a delayed reaction and /or post inflammatory hyperpigmentation 1-2 cm in each direction with possible permanent dark marking of the skin. Patient possibly treated with steroids (prednisone dose pak), or went to er, and /or went to dermatologist. Prineo was removed at 3 or 4 weeks. The reaction dominated patients post op course. Pictures of the reactions may be forwarded. Specific patient history was not known, however there were no obvious history of allergies. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Please forward pictures of the reaction.
 
Manufacturer Narrative
The actual device batch number associated with this event is not known. The possible batch numbers are reported as follows: batch lot lhh607 - mfg. Date - 7/27/2017; exp. Date - 6/6/2019 batch ldh420 - mfg. Date - 4/21/2017; exp. Date - 3/20/2019 batch lbh800 - mfg. Date - 2/20/2017 ; exp. Date - 1/15/2019 in addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.
 
Manufacturer Narrative
(b)(4). Additional information: the actual device batch number associated with this event is not known. The possible batch numbers are reported as follows: batch lhh607; batch ldh420; batch lbg800. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What is the initial procedure date? procedure name? how was the device applied to the incision? what layer of tissue and how many layers applied? what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur on? what does the reaction look like and how large of an area does the reaction cover? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Can you identify the product code and lot number of the product that was used? 3 lot numbers were reported (lhh607; ldh4202; lbg800), were all these used in all procedures? or are these possible lot numbers? ldh4202 is an invalid lot number, please provide the correct lot. Will any device be returned for evaluation? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were the patients exposed to similar products, such as artificial nails? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions). Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that a patient underwent a breast procedure on an unknown date and topical skin adhesive was used to close the incision. The patient returned with redness and bumps along the incision line and possible rash that spread to the face. The topical skin adhesive was removed and the patient was possibly treated with prescribed antibiotics. As of today, the patient is doing better. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7206291
MDR Text Key106650644
Report Number2210968-2018-70337
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2018 Patient Sequence Number: 1
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