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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 CLR602US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Erythema (1840); Inflammation (1932); Reaction (2414); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. Do you know if both of the leg incisions dehisced or only 1 incision dehisced? do you know what treatment was provided for the incision(s) that dehisced? please provide any medical or surgical interventions that were performed? what is the procedure date? how was the device was used (what layer of tissue and how many layers applied)? what was the location and incision size of prineo application? what prep was used prior to prineo application? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? was the mesh placed over the entire length of the incision? was the dermabond liquid adhesive placed to cover the entire length of the mesh? did the prineo mesh extend beyond the patient incision? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and let dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? do you have any pictures of the reaction? what was done to address the reaction? were prescription steroids administered? if so, what type of medication was used to treat the reaction? what was the dosage? when (date) was the medication administered? were antibiotics prescribed? what type of medication was used to treat the reaction? what was the dosage? when (date) was the medication administered? was there any medical or surgical intervention to treat the reaction? if so, please clarify. Was another method used to close the incision? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? can you identify the product code and lot number of the product that was used? 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 previously used on the patient in a previous surgery? if yes what was the outcome of previous surgery?.
 
Event Description
It was reported that the patient underwent a cabg procedure on approximately (b)(6) 2017 and the topical skin adhesive was used on both legs. After the procedure, the patient developed severe redness on both legs around the whole area where the topical skin adhesive was applied. It was unknown how long after the procedure the patient developed this reaction. The incision was dehisced because the topical skin adhesive was removed prematurely and, as per the doctor's opinion, by the patient. The surgeon removed the product, but it was unknown what other treatment was provided, if any. It was also reported that the patient was grossly fluid overloaded and had cellulitis and an open harvest. 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 PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6545263
MDR Text Key74435995
Report Number2210968-2017-31937
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602US
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 Received04/18/2017
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: 05/04/2017 Patient Sequence Number: 1
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