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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 103