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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 Reaction (2414); No Code Available (3191)
Event Date 03/24/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts have been made to retrieve the device. 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 following 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 have any pictures of the reaction? procedure date. Location and incision size of product application? what prep was used prior to perineo use? was the prep allowed to dry prior to perineo 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? 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 allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? date of reaction. How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape what type of medications were prescribed? dose? when (date) administered? 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? lot number involved. What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). For female patients : was the patient previously exposed to similar products, such as artificial nails. Was perineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that the patient underwent a l1 - s1 spine laminectomy procedure on (b)(6) 2017 and the topical skin adhesive was used. Following the procedure, the patient experienced severe blistering and underwent a para incisional sterile drainage on post op day 4. The topical skin adhesive was removed and wound has healed with no infection. Additional information has been requested.
 
Manufacturer Narrative
Date sent to fda: 5/26/2017. Additional information was requested and the following was obtained: ¿ do you have any pictures of the reaction?yes. Sent today 5,26,17 ¿ location and incision size of product application? l1-s1 laminectomy - 20 cm prineo patch ¿ what prep was used prior to prineo use? yes ¿ was the prep allowed to dry prior to prineo mesh application? yes ¿ please describe how the adhesive was applied on the tape? same way they have always done it ¿ 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 ¿ was incision re-prepped before closure? no if so, with what? if so, was the prep allowed to dry? ¿ was the skin prep solution wiped off and allowed to dry before applying adhesive? yes ¿ was a dressing placed over the incision? no if so, what type of cover dressing used? ¿ date of reaction- 4 days post op ¿ how large of an area does the reaction cover? 20 cm ¿ did the skin reaction extend beyond the borders of the tape - not really per the picture ¿ what type of medications were prescribed? dose? when (date) administered? un known ¿ was another method used to close the incision? no ¿ is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no ¿ is the patient hypersensitive to pressure sensitive adhesives? ¿ lot number involved ¿ what is the physicians opinion of the contributing factors to the reaction? unknown ¿ what is the most current patient status? unknown ¿ patient demographics: initials / id; age or date of birth; bmi ; gender. Unknown ¿ patient pre-existing medical conditions (ie. Allergies, history of reactions) unknown ¿ for female patients: was the patient previously exposed to similar products, such as artificial nails unknown ¿ was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?no.
 
Manufacturer Narrative
(b)(4).
 
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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 Key6516900
MDR Text Key73557126
Report Number2210968-2017-31773
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? No
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: 04/24/2017 Patient Sequence Number: 1
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