• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12617355
MDR Text Key283613149
Report Number2210968-2021-09565
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K082289
Number of Events Reported1
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 Received10/12/2021
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 Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
-
-