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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). The following information was requested, however not obtained to date: patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? please describe how was the adhesive was applied on the tape what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? do you have the product code and/or lot number involved? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient pre-existing medical conditions (ie. Allergies, history of reactions) was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? 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.

Event Description

It was reported a patient underwent a knee replacement surgery on (b)(6) 2019 and topical skin adhesive was used. Two weeks postop, (b)(6) 2019 adhesive was removed by doctor. The patient had a surgical site infection. At that time a small amount of drainage was noted at the distal end of the incision. The wound was cleaned with betadine and dressed with a 4 x 4. 6/17 culture positive for enterobacter cloacae and keflex started. (b)(6) patient underwent ¿washout¿ at a different hospital. Femoral and synovial cultures were negative. Additional information was requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• 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; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8916588
• MDR Text Key: 155084398
• Report Number: 2210968-2019-85949
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/26/2019
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/21/2019 Patient Sequence Number: 1