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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEADOX MEDICAL, INC.HEMASHIELD KNITTED DOUBLE VELOUR FABRICCARDIOVASCULAR FABRIC

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MEADOX MEDICAL, INC. HEMASHIELD KNITTED DOUBLE VELOUR FABRIC CARDIOVASCULAR FABRIC   Back to Search Results
Model Number 019508
Device Problems Leak; Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 06/20/1999
Event Type  Injury   Patient Outcome  Other,Required Intervention,Hospitalization
Manufacturer Narrative

Since nothing is to be returned for eval, the incident cannot be confirmed, or denied. Note: items marked "ni" are not available at this time. Should such info become available, it will be included in a follow-up report. Section "f" completed by mfr. The device history records were reviewed. All mfg and quality assurance testing was carried out in accordance with the co's standard procedures. The device history record for this batch shows that the product met it's specifications at the time of release to distribution - there are no similar incidents against this batch.

 
Event Description

The hosp claims that the fabric was implanted in 1999 as an angioplasty patch for a right carotid endarectomy procedure. 2 days post operative, the pt was re-admitted due to a [large] right neck hematoma. 3 days later, evacuation of the hematoma was performed. The patch was left in. The pt's post-operative condition is fine. The surgeon reported that the hematoma was partially due to the hemashield patch.

 
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Brand NameHEMASHIELD KNITTED DOUBLE VELOUR FABRIC
Type of DeviceCARDIOVASCULAR FABRIC
Baseline Brand NameHEMASHIELD KNITTED DOUBLE VELOUR
Baseline Generic NameCARDIOVASCULAR FABRIC
Baseline Catalogue Number019508
Baseline Model Number019508
Baseline Device FamilyHEMASHIELD KNITTED FABRIC
Baseline Device 510(K) NumberK955349
Baseline Shelf Life Information Yes
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed05/27/1993
Manufacturer (Section F)
MEADOX MEDICAL, INC.
112 bauer dr.
oakland NJ 07436 3105
Manufacturer (Section D)
BOSTON SCIENTIFIC/VASCULAR
103 bauer drive
oakland NJ 07436
Manufacturer Contact
mel pollinger
103 bauer dr
oakland , NJ 07436
(973) 709 -7336
Device Event Key236958
MDR Report Key244598
Event Key229465
Report Number6000072-1999-00068
Device Sequence Number1
Product CodeDXZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/09/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/01/2003
Device MODEL Number019508
Device Catalogue Number019508
Device LOT Number1849057
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/18/1999
Device Age8 mo
Event Location Hospital
Date Report TO Manufacturer09/09/1999
Date Manufacturer Received09/09/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/06/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
NI
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