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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 CLR602
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Irritation (1941); Rash (2033); Skin Irritation (2076); Reaction (2414); No Code Available (3191)
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 a 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 a later date a supplemental medwatch will be sent. Was the case discussed in this article previously reported to ethicon? initial procedure date. Is the product code and lot number involved? patient pre-existing medical conditions (ie. Allergies, history of reactions) was the patient exposed to similar products, such as artificial nails was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? was the initial agent that helped closed the skin prineo or was the only non-suture skin closure the tape in the pictures we see in the article? what was used to reinforce the skin closure?.
 
Event Description
It was reported in a journal article that a (b)(6) female collegiate diver with previous left elbow injuries underwent a surgery to repair the left elbow¿s instability on an unknown date and topical skin adhesive was used. The patient developed a rash post surgery. Evaluation by the team physician revealed irritation around each of the suture sites. The skin around the posterior elbow was red, warm to touch and inflamed. A small amount of oozing coming from the patient wounds appeared appeared to be clear, odorless fluid. The doctor prescribed clindamycin 300mg tib for 10 days. The rash did not improve over the course of the 10 days. The patient athlete began a course of prednisone 20mg bid. The athlete¿s arm was cleaned daily with hibiclens, antimicrobial antiseptic skin cleanser, and the suture strips started slowly to come off and the rash began to improve. It was reported that povidone-iodine reaction could have also been a cause of the rash. The doctor determined that the athlete had contact dermatitis from the topical skin adhesive used to close the sutures. Once the contact dermatitis began to subside, the athlete moved forward with rehabilitation as planned. 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 08876 0151
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7036231
MDR Text Key92156993
Report Number2210968-2017-71266
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/15/2017 Patient Sequence Number: 1
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