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

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.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL 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 Key: 7036231
• MDR Text Key: 92156993
• Report Number: 2210968-2017-71266
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Health Professional
• 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 Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• 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: 19 YR
• Patient Weight: 54