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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
Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Reaction (2414); No Code Available (3191)
Event Date 05/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) date sent to the fda: 08/29/2016. (b)(4). 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. Additional information was requested and the following was obtained: certified physician assistant confirmed that there has been no changes on surgical products (skin preps, wound closure materials, dressings, etc. ), techniques, or procedures associated with the reported skin reaction. Procedure date - unknown. How the device was used (what layer of tissue and how many layers applied)? one layer applied to outer skin at incision. Location and incision size of product application? hip about 6 cm in length. What prep was used prior to prineo use? pre-operative prep
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chlorhexidine gluconate ¿ applied and air dry, duraprep ¿ one layer and allow to dry, apply drape and loban, after the procedure, remove loban, wipe down skin with sterile water and allow skin to dry completely, then apply one layer of prineo to the outer skin. Was the prep allowed to dry prior to prineo mesh application? yes. Please describe how the adhesive was applied on the tape? applied per ifu. Was the mesh placed over the entire length of the incision? yes. Was the dermabond liquid adhesive placed to cover the entire length of the mesh? yes. Did the prineo mesh extend beyond the patient incision? no. Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? after the procedure, remove loban, wipe down skin with sterile water and allow skin to dry completely, then apply one layer of prineo to the outer skin. Was the skin prep solution wiped off and let dry before applying adhesive? yes. Was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex placed over incision. Date of reaction (b)(6) 2016. What does the reaction look like? please provide details. Blistering, redness, itching, irritation. How large of an area does the reaction cover? the area is slightly larger than the area the product covered. Do you have any pictures of the reaction? yes. What was done to address the reaction? removed product, cleaned skin with alcohol and applied betadine then applied steristrips over the incision. The patient was prescribed seven days of broad spectrum antibiotic bactrim to prevent infection. There was no sign of infection however. What type of medication? dose? when (date) administered? bactrim prescribed on (b)(6) 2016. Was the product removed? was another method used to close the incision? yes. Yes, steristrips was the site cultured? if so, what bacteria were identified? no, as there was no sign of infection. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no, not that the patient was aware of. Is the patient hypersensitive to pressure sensitive adhesives? no. Were any patch or sensitivity tests performed? no. Product code and lot number involved clr222us, lot# unknown. What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? the symptoms have improved since removal of the product, there are some residual skin changes at the site the product was used. Is the product or representative sample (product from the same lot number) available for evaluation? no. Patient demographics: initials / id; age or date of birth; bmi ; gender ¿ female. More details may be available from the pa. Patient pre-existing medical conditions (ie. Allergies, history of reactions) ¿ no history of sensitivity to adhesives, tape or demabond. More information may be available with the pa. For female patients ask if they were exposed to similar products, such as artificial nails ¿ the patient did not have a history of reaction to artificial nails. Was prineo previously used on the patient in a previous surgery? no. The patient had been exposed to dermabond previously, with no history of sensitivity to dermabond.
 
Event Description
It was reported that the patient underwent a total hip replacement procedure on unknown date and one layer of topical skin adhesive was applied to outer skin at incision. After the procedure, mepilex dressing was placed over incision. Following the procedure, on (b)(6) 2016, the patient returned to the doctor's office with blistering, itching, redness and irritation, and the area of reaction was slightly larger than the area the topical skin adhesive covered. The topical skin adhesive was removed, skin was cleaned with alcohol and betadine was applied then steristrips was applied over the incision. The patient was prescribed seven days of broad spectrum antibiotic bactrim to prevent infection. It was also reported that there was no sign of infection however. The symptoms have improved since removal of the topical skin adhesive, there are some residual skin changes at the site the topical skin adhesive was used. The physician assistant opined that there have been no changes on surgical products, skin prep, wound closure materials, dressings, techniques, or procedures associated with the reported skin reaction.
 
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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 PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5910565
MDR Text Key53374369
Report Number2210968-2016-11661
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 08/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2016
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/29/2016 Patient Sequence Number: 1
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