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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DSM BIOMEDICAL MESO BIOMATRIX; MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY
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DSM BIOMEDICAL MESO BIOMATRIX; MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Manufacturer has made numerous attempts to obtain additional information without success.There has been no design history review as no product information has been provided to date.Device not returned.
 
Event Description
The surgeon reported that, post-mastectomy, a patient returned to the operating room for implant exchange and explantation of the meso biomatrix.He stated that he saw a "jelly-like" substance during the explantation.No other information is available at this time.
 
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Brand Name
MESO BIOMATRIX
Type of Device
MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY
Manufacturer (Section D)
DSM BIOMEDICAL
735 pennslyvania drive
exton PA 19341
Manufacturer Contact
forde hansell
735 pennsylvania
exton, PA 19341
4847132152
MDR Report Key6118763
MDR Text Key60621608
Report Number2530154-2016-00016
Device Sequence Number1
Product Code OXH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K090134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/12/2016
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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