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

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.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL 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 Key: 9488233
• MDR Text Key: 188036174
• Report Number: 2210968-2019-91047
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• 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 Received: 12/18/2019
• 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 Received: 02/19/2020
• 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