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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Not Applicable (3189); No Code Available (3191)
Event Date 05/22/2018
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. Additional information was requested and the following was obtained: what is the initial procedure date? (b)(6) 2018, however, the derma bond was not placed until (b)(6) 2018. How was the device applied to the incision mesh placed, then glue applied on top. Please describe how the adhesive was applied on the tape the glue was applied on top of mesh. Three layers total. Glue was spread gernously around the edge of mesh overlapping onto the skin. What prep was used prior to product application? original dressing was skinafix. On (b)(6) 2018 went to surgeon office due to allergic reaction on skin (had rash). It was clear he had a reaction to the cholahexadin used for surgical prep, but also looked like he was having a reaction to the skinafix covering, and it was peeling a way and leaking fluid. That dressing was removed with adhesive remover. She then applied dermabond. What was the location and incision size of the application? on front of neck, about 2 inches long. Was a dressing placed over the incision? if so, what type of cover dressing used? yes. I saw her cut a piece of mesh and then apply derma bond via a glue pen. No other dressing beside that. What date did the reaction occur on? (b)(6) 2018. What does the reaction look like and how large of an area does the reaction cover? he developed weeping blisters where the mesh and glue touched his skin. He also developed a rash where the glue touched his skin. When she removed the dermabond in the or, we asked her to place a small area on each arm containing both a derma bond dressing and a skinafix dressing, so that we could make sure we know which he was reacting to. 2 days later both arms had a reaction (rash, no blisters). The derma bond side was more red and bumpy though. Do you have any pictures of the reaction? yes, please see attached photos. One is the blisters with the derma bond. One is what the wound looks like now, the others are of the ¿trials¿ on his arms with the dressings and then 2 days after they were taken off. 10. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. On (b)(6) 2018 he went back into the or to have the bandage removed, wound washed out, and was left to heal with only gauze. He was prescribed clindamyacin as precaution. Was also given benadryl to help with the itchy rash. Can you identify the product code and lot number of the product that was used? doctor may. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not known. For female patients, were they exposed to similar products, such as artificial nails? n/a. What is the most current patient status? wound is healing well. Skin where the derma bond touched is very dry and peeling. Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) (b)(6), no history of allergies prior to surgery. Surgeon believes he is allergic to chrolahexadin, and skin adhesive (surgical grade). Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? on (b)(6) 2018, he had surgery at the same sight. Skinafix was used for a dressing. No signs of allergic reaction to the adhesive.
 
Event Description
It was reported that a patient underwent a fistula cis trunk hyoid bone removal on (b)(6) 2018 in the front of the neck by the thyroid approximately two inches long. The topical skin adhesive was not placed until (b)(6) 2018. The original dressing was skinafix. On (b)(6) 2018 the patient went to the surgeon office due to allergic reaction on skin ( rash). The patient had a reaction to the chlorhexidine used for surgical prep, but also looked like he was having a reaction to the skinafix covering, and it was peeling away and leaking fluid. That dressing was removed with adhesive remover. The surgeon then applied the topical skin adhesive. The reaction occurred on (b)(6) 2018. The patient developed weeping blisters where the topical skin adhesive touched his skin. The patient was brought back to operating room on (b)(6) 2018 to have the bandage and topical skin adhesive removed, wound washed out and was left to heal with only gauze. The surgeon placed a small area of the topical skin adhesive and skinafix dressing on each arm, to test for the reaction. Two days later both arms had a reaction, red and bumpy (rash, no blisters). The patient was prescribed clindamyacin as precaution and was also given benadryl to help with the itchy rash. The patient had no history of allergies prior to the surgery. The surgeon opines that the patient is allergic to chlorhexidine and topical skin adhesive (surgical grade). The patient had a previous surgery on (b)(6) 2018 at the same sight and skinafix was used for the dressing with no signs of allergic reaction to the adhesive. Additional information has been requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7650678
MDR Text Key112747620
Report Number2210968-2018-73936
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2018
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: 06/29/2018 Patient Sequence Number: 1
Treatment
SKINAFIX, CHLORAHEXADINE
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