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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 Itching Sensation (1943); Rash (2033); Reaction (2414); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Date sent to the fda: 10/11/2016. (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: what is the procedure name? pao. What is the procedure date? unknown. How was the device was used (what layer of tissue and how many layers applied)? 1 layer used topically on skin. What was the location and incision size of prineo application? 10-12 cm on the hip. What prep was used prior to prineo application? chloraprep in the beginning of the case. No prep prior to use of prineo. Was the prep allowed to dry prior to prineo mesh application? n/a. Please describe how the adhesive was applied on the tape? tape was applied over the incision flush and patted down to assure adherence. 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? yes. Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? n/a. Was the skin prep solution wiped off and let dry before applying adhesive? unknown. Was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex standard. What date did the reaction occur on? patient called on the 3rd or 4th day, saw patient on the 6th day post-op. What does the reaction look like? please provide details. ¿ rash, blistering, itchiness around where dermabond was applied, even beyond the tape. How large of an area does the reaction cover? the entirety of the mesh tape and beyond the perimeter of the mesh. Do you have any pictures of the reaction? yes, attached. What was done to address the reaction? patient was told to remove with vaseline and prescribed a steroid cream. What type of medication was used to treat the reaction? clobetasol a. What was the dosage?. 05%. B. When (date) was the medication administered? 3-4 days post-op, unknown if patient applied it right away. Was the product removed? was another method used to close the incision? yes by patient. No. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? none known to cyanoacrylates or formaldehyde. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? no. Can you identify the lot number of the product that was used? no.
 
Event Description
It was reported that the patient underwent a periacetabular osteotomy procedure on unknown date and the topical skin adhesive was applied on the skin with one layer. Chloraprep was used at the beginning of the procedure. It was also reported that cover mepilex dressing was placed over the incision. On the third or fourth day of post-op, the patient reported a skin reaction and was told to remove the topical skin adhesive with vaseline. The doctor saw the patient on the sixth post-op day and observed itching, blistering and rash around where topical skin adhesive was applied, even beyond the tape. The topical skin adhesive was removed and 0. 05% clobetasol steroid cream was prescribed.
 
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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 Key6017131
MDR Text Key56995869
Report Number2210968-2016-14309
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 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2016
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 Received09/22/2016
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: 10/11/2016 Patient Sequence Number: 1
Treatment
MEPILEX STANDARD
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