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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 Hypersensitivity/Allergic reaction (1907); Rash (2033); No Code Available (3191)
Event Date 05/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Date sent to the fda: 06/20/2017. 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. Additional information was requested and the following was obtained: what is the procedure date?- (b)(6) 2017. How was the device was used (what layer of tissue and how many layers applied)? skin closure system, on the skin. One layer was applied. What was the location and incision size of prineo application?- back (spine), 12-15cm. What prep was used prior to prineo application?- sterile saline water. Was the prep allowed to dry prior to prineo mesh application?- yes. Please describe how the adhesive was applied on the tape?- applied on the skin. 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?- nope. Was the skin prep solution wiped off and let dry before applying adhesive?- na. Was a dressing placed over the incision? if so, what type of cover dressing used?- nope. What date did the reaction occur on?- (b)(6) 2017. How large of an area does the reaction cover?- entire mesh. Do you have any pictures of the reaction?- nope. What was done to address the reaction?- remove prineo. Prescribed steroid. Were prescription steroids administered? if so, what type of medication was used to treat the reaction? hydrocortisone. What was the dosage? sparing application daily. When (date) was the medication administered? (b)(6) 2017. Were antibiotics prescribed? no. What type of medication was used to treat the reaction? na. What was the dosage? - na. When (date) was the medication administered? na. Was there any medical or surgical intervention to treat the reaction? if so, please clarify. - steroid cream. Was the product removed? was another method used to close the incision?- yes. Steri-strip. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde?- no. Is the patient hypersensitive to pressure sensitive adhesives?- n. Were any patch or sensitivity tests performed?- no. What is the most current patient status?- recovered. Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions)- no history. Was prineo previously used on the patient in a previous surgery?- no.
 
Event Description
It was reported that the patient underwent a spine procedure on (b)(6) 2017 and the topical skin adhesive was used on the skin as one layer. After the procedure, the patient developed rash and allergic reaction on spine incision. The topical skin adhesive was removed and closed with steri strips. The medication was applied on (b)(6) 2017. The patient was treated with prescribed steroid cream hydrocortisone. Currently, the patient recovered.
 
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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 Key6653235
MDR Text Key77971725
Report Number2210968-2017-32676
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
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 Received05/27/2017
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: 06/20/2017 Patient Sequence Number: 1
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