Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION BILAYER MATRIX WOUND DRESSING 2X2 SINGLE; BMWD
  • 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
 

INTEGRA LIFESCIENCES CORPORATION BILAYER MATRIX WOUND DRESSING 2X2 SINGLE; BMWD Back to Search Results
Catalog Number BMW2021
Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)
Patient Problem Injury (2348)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A nurse reported that on (b)(6) 2018, during a craniotomy for a recurrent tumor, a bmw2021 (bilayer matrix wound dressing 2x2 single) was implanted instead of a duragen.When medical staff discovered that they implanted a wound dressing on the brain instead of duragen, the surgeon wanted to bring the patient back to operating room approximately 24 hours later to implant the duragen.No patient consequences reported, and the patient¿s current condition is fine.Patient is a female in her 70¿s.Staff and physician felt that the packaging was not clear which lead to use of the incorrect product.
 
Manufacturer Narrative
The device was not returned for evaluation therefore the failure analysis to identify root cause to the end users experience could not be determined.No product lot number was provided with this complaint.A serial number that looked like a lot number was provided.However, this is not a valid lot number either.Therefore, dhr review cannot be performed.All skin product goes through incoming inspection post-sterilization for labeling and boxing inspection post-boxing.Each type of product is clearly packaged in a box containing artwork and labeling for that product only.In addition, the box also contains the indications of use.Therefore, the likelihood that ¿unclear packaging¿ led to use of wrong product is very low.Since no valid lot number or pictures of product/ packaging were provided, the root cause cannot be determined.
 
Event Description
N/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BILAYER MATRIX WOUND DRESSING 2X2 SINGLE
Type of Device
BMWD
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
105 morgan lane
105 morgan lane
plainsboro NJ 08536
MDR Report Key8354296
MDR Text Key136645917
Report Number1121308-2019-00003
Device Sequence Number1
Product Code FRO
Combination Product (y/n)N
PMA/PMN Number
K021792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberBMW2021
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-