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

Catalog Number CLR222

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/09/2016

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.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.

Event Description

It was reported that the patient underwent a hip prosthesis surgical procedure on (b)(6) 2016 and the topical skin adhesive was used.On (b)(6) 2016, a surgeon informed that the patient developed infection on the operating site.It was also reported that the outcome of this infection is still unclear, but further follow-up will be done together with the surgeon.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 NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6212580
• MDR Text Key: 63507703
• Report Number: 2210968-2016-15662
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• 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