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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
(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. 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. What was the date of the procedure in 2011? what suture was used during procedure in 2011? what was the date of the second procedure? what suture was used during second procedure? if in your possession, may we have a copy of your operative report (2011, 2nd proc, and aug 2019) for each procedure to review which layer of tissue the suture was used? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact the surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the surgeon¿s name, contact information and sign release of medical information form. Patient reported adverse event of hives, reaction possibly treated with steroid in 2011 reported via 2210968-2019-90131. Patient reported adverse event of hives, reaction and angioedema treated with steroid on unknown date reported via 2210968-2019-90134, 2210968-2019-90135 and 2210968-2019-90137. Patient reported adverse event of hives, reaction, angioedema treated with steroid in (b)(6) 2019 and current hives reported via 2210968-2019-90138, 2210968-2019-90140 and 2210968-2019-90141.
 
Event Description
It was reported by the patient that they underwent a left total knee arthroplasty utilizing smith nephew system on (b)(6) 2019 and topical skin adhesive was used. The extensor mechanism was tacked with absorbable suture in figure eight followed by running barbed suture. The subcutaneous closure with absorbable suture in running fashion. The subcuticular closure was performed with absorbable suture. Skin adhesive dressing and mildly compressing wrap were applied. The patient tolerated the procedure well. The patient experienced severe allergic reactions 3 to 4 weeks after surgery, not at the site of surgery but systemically with hives and angioedema. The reaction begins with hives and then proceeds to swelling in the face and lips or on the tongue. The patient reported the angioedema usually responds well but can reappear mildly up to two months, and the hives last longer. The patient was treated with tapering doses of prednisone. Patient reported current hives continue. Additional information has been requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.SAN LORENZO
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9488233
MDR Text Key188036174
Report Number2210968-2019-91047
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/19/2020
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2019 Patient Sequence Number: 1
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