DURAMATRIX-ONLAY CDSLM33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-13 for DURAMATRIX-ONLAY CDSLM33 manufactured by Collagen Matrix, Inc..

Event Text Entries

[188662287] It was reported that a surgeon observed a csf leak through the dmo in posterior fossa. The surgeon was able to complete the procedure using another product. There was no delay in procedure reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2249852-2020-00002
• MDR Report Key: 9706844
• Report Source: DISTRIBUTOR,HEALTH PROFESSION
• Date Received: 2020-02-13
• Date of Report: 2020-02-13
• Date of Event: 2020-01-14
• Date Mfgr Received: 2020-01-16
• Device Manufacturer Date: 2019-04-30
• Date Added to Maude: 2020-02-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. GLORIA ZUCLICH
• Manufacturer Street: 15 THORNTON ROAD
• Manufacturer City: OAKLAND, NJ
• Manufacturer Country: US
• Manufacturer G1: COLLAGEN MATRIX, INC.
• Manufacturer Street: 15 THORNTON ROAD
• Manufacturer City: OAKLAND, NJ
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DURAMATRIX-ONLAY
• Generic Name: COLLAGEN DURA SUBSTITUTE MEMBRANE
• Product Code: GXQ
• Date Received: 2020-02-13
• Model Number: CDSLM33
• Catalog Number: CDSLM33
• Lot Number: 1904172022
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COLLAGEN MATRIX, INC.
• Manufacturer Address: 15 THORNTON ROAD OAKLAND, NJ US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-13