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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO SURGICAL SEALANT Back to Search Results
Catalog Number CLR222
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Irritation (2076); No Code Available (3191)
Event Date 07/18/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. 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. Can you identify the lot number of the product that was used? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? what in the physicians opinion are the contributing factors to the event? how was the device applied to the incision, describe how the adhesive was applied on the tape 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 lot number of the product that was used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? for female patients ask if they were 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 total knee replacement procedure on (b)(6)2017 and topical skin adhesive was used. The incision was a medial para-patellar approach through a previous incision. Chloraprep was used for pre op skin prep. After surgery, the topical skin adhesive was applied per routine and covered with primapore. Primapore was changed daily for two days, then left on for seven days. Primapore was removed post-op day seven. On post op day fourteen (usual post op appointment), the patient was in the office and the topical skin adhesive was removed, revealing an erythematous rash in shape of a rectangle where the topical skin adhesive was applied. There was slight drainage from incision, but no dehiscence. The patient complained of itching/ pruritis around the incision where the papular, weeping dermatitis/ folliculitis rash was located. The patient was told to use benadryl and follow up in one week. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO
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 Key6844720
MDR Text Key84963466
Report Number2210968-2017-70195
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/06/2017 Patient Sequence Number: 1
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