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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Swelling (2091); Reaction (2414); No Code Available (3191)

Event Date 09/22/2016

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.Additional information was requested and the following was obtained: what was the location and incision size of prineo application; back about 19cm; what prep was used prior to prineo application: yes; please describe how the adhesive was applied on the tape: per directions; was a dressing placed over the incision, if so, what type of cover dressing used: no as the prineo was removed immediately; do you have any photos: no!; does the patient have any other exposure to adhesives (nail glue): unknown; when the product was removed, what was another method used to close the incision:yes; is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde: unknown; can you identify the lot number of the product that was used: no; what is the current condition of the patient: unknown.

Event Description

It was reported that the patient underwent a laminectomy procedure for l4-5 on (b)(6) 2016 and the topical skin adhesive was used.During the procedure, after applying a topical skin adhesive, the patient's skin immediately began to turn red and puffy underneath it; therefore, the doctor decided to remove it.It was also reported that steroids, strips, mastisol, dry 4x3's and tape were used to complete the procedure.The current condition of the patient is unknown.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6020250
• MDR Text Key: 57073004
• Report Number: 2210968-2016-14324
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR