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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELA BIO OVITEX PRS SURGICAL MESH

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TELA BIO OVITEX PRS SURGICAL MESH Back to Search Results
Model Number R20152-2020G
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient was non-compliant with her drains after surgery. It is unknown whether this caused or contributed to the event or whether the indication for the follow-up surgical procedure was related to the noted state of the ovitex prs. A dhr review revealed no anomalies that may have caused or contributed to this event.
 
Event Description
A patient underwent a unilateral (left) mastectomy and prefectoral two-stage breast reconstruction with a textured tissue expander and ovitex prs. The expander and ovitex prs were implanted on (b)(6) 2020. The patient returned on (b)(6) 2020 for an unknown follow-up surgical procedure. Upon opening the incision, the surgeon noted that portions of the ovine tissue were no longer present at the surgical site. The surgeon removed the ovitex prs and left the expander inserted.
 
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Brand NameOVITEX PRS
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
TELA BIO
1 great valley parkway
suite 24
malvern PA 19355
Manufacturer Contact
john urtz
1 great valley parkway
suite 24
malvern, PA 19355
4843202884
MDR Report Key10822213
MDR Text Key215887640
Report Number3010513348-2020-00006
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberR20152-2020G
Device Catalogue NumberR20152-2020G
Device Lot NumberERT-20G02
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/11/2020 Patient Sequence Number: 1
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