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 Hemorrhage/Bleeding (1888)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). If further details are received at a later date a supplemental medwatch will be sent. No product is available for return. Note: events reported on mw# 2210968-2021-09540, mw# 2210968-2021-09541, mw# 2210968-2021-09542.

Event Description

It was reported a patient underwent surgical intervention debridement / washing and change of liner and femoral head on (b)(6) 2021 from a total hip arhroplasty of (b)(6) 2021 and topical skin adhesive was used. On (b)(6) 2021 (post op day # 29, po review # 4) patient went to emergency visit with uncompressible bleeding. Fine wound, no redness. Liquid discharge tinged with blood. On (b)(6) 2021 patient was hospitalized. On (b)(6) 2021, surgery of debridement / washing and change of liner and femoral head by dr. Closure with sutures and mepilex. Continuation of the follow-up with microbio and aaiv [ancef iv then addition of rifampin po]. Superficial and deep pus: absence of staph aureus. Post revision microbiology monitoring: (b)(6) 2021 nothing special. (b)(6) 2021 - 2 residual points found and removed. Persistent flow but point found and removed. (b)(6) 2021, iv ancef ceased, addition of levofloxacin po + rifampin po. Post-revision ortho follow-up: (b)(6) 2021 nothing special: review (b)(6) 2021-09-15 no notes on teaching and advice related to hygiene and asepsis. Additional information requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12617355
• MDR Text Key: 283613149
• Report Number: 2210968-2021-09565
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/14/2021

Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data

Date Received: 10/12/2021 Patient Sequence Number: 1