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

Catalog Number CLR222

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 05/25/2017.(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 the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Did the infection mrsa occur with patient prior to prineo application or after the prineo application? date of (b)(6) infection and how was the infection treated? date that it was noticed that prineo did not stick to the wound?.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the topical skin adhesive was used.Three weeks post-op, event occurred.The topical skin adhesive did not stick to the wound and the wound was treated like open wound and steri strips were placed.It was also reported that the patient experienced infection (b)(6).Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was obtained: did the infection (b)(6) occur with patient prior to prineo application or after the prineo application? after application of the prineo date of (b)(6) infection and how was the infection treated? (b)(6).Date that it was noticed that prineo did not stick to the wound? (b)(6).When was the prineo placed (during the initial procedure or 3 weeks post op)? during the initial procedure.Initial procedure date - (b)(6).How was the infection treated? unknown.What was the indication for initial procedure? unknown.Procedure name -unknown.Size of incision ¿ unknown.Were any ointments used prior to using product application? ¿ unknown.Type of skin preparation used? ¿ unknown.Please describe how the adhesive was applied on the tape? ¿ unknown.Was incision re-prepped before closure? if so, with what? ¿ unknown was a dressing placed over the incision? if so, what type of cover dressing used? ¿ unknown.Lot number involved - unknown.What is the physicians opinion of the contributing factors to the event? ¿ unknown.What is the most current patient status? ¿ unknown.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi ; gender ¿ unknown.Patient pre-existing medical conditions ¿ unknown.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: what is the physicians opinion of the contributing factors to the event? ¿ surgeon doesn¿t think that prineo is the root cause.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6590974
• MDR Text Key: 75962743
• Report Number: 2210968-2017-32287
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: No
• 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