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 Itching Sensation (1943); Rash (2033); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Date sent to the fda: 10/11/2016. (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 is the procedure name? pao. What is the procedure date? unknown. How was the device was used (what layer of tissue and how many layers applied)? 1 layer used topically on skin. What was the location and incision size of prineo application? 10-12 cm on the hip. What prep was used prior to prineo application? chloraprep in the beginning of the case. No prep prior to use of prineo. Was the prep allowed to dry prior to prineo mesh application? n/a. Please describe how the adhesive was applied on the tape? tape was applied over the incision flush and patted down to assure adherence. Was the mesh placed over the entire length of the incision? yes. Was the dermabond liquid adhesive placed to cover the entire length of the mesh? yes. Did the prineo mesh extend beyond the patient incision? yes. Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? n/a. Was the skin prep solution wiped off and let dry before applying adhesive? unknown. Was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex standard. What date did the reaction occur on? patient called on the 3rd or 4th day, saw patient on the 6th day post-op. What does the reaction look like? please provide details. ¿ rash, blistering, itchiness around where dermabond was applied, even beyond the tape. How large of an area does the reaction cover? the entirety of the mesh tape and beyond the perimeter of the mesh. Do you have any pictures of the reaction? yes, attached. What was done to address the reaction? patient was told to remove with vaseline and prescribed a steroid cream. What type of medication was used to treat the reaction? clobetasol a. What was the dosage?. 05%. B. When (date) was the medication administered? 3-4 days post-op, unknown if patient applied it right away. Was the product removed? was another method used to close the incision? yes by patient. No. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? none known to cyanoacrylates or formaldehyde. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? no. Can you identify the lot number of the product that was used? no.

Event Description

It was reported that the patient underwent a periacetabular osteotomy procedure on unknown date and the topical skin adhesive was applied on the skin with one layer. Chloraprep was used at the beginning of the procedure. It was also reported that cover mepilex dressing was placed over the incision. On the third or fourth day of post-op, the patient reported a skin reaction and was told to remove the topical skin adhesive with vaseline. The doctor saw the patient on the sixth post-op day and observed itching, blistering and rash around where topical skin adhesive was applied, even beyond the tape. The topical skin adhesive was removed and 0. 05% clobetasol steroid cream was prescribed.

• 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: 6017131
• MDR Text Key: 56995869
• Report Number: 2210968-2016-14309
• 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

• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR222US
• 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: 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 Treatment Data

Date Received: 10/11/2016 Patient Sequence Number: 1

Treatment

MEPILEX STANDARD