2800-000-000 35X84 P NYLA IMR000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-11 for 2800-000-000 35X84 P NYLA IMR000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[4129564] It was reported via repair work order that the top cover had fluid ingress. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2014-01176
• MDR Report Key: 3621964
• Report Source: 06
• Date Received: 2014-02-11
• Date of Report: 2014-01-14
• Date of Event: 2014-01-14
• Date Mfgr Received: 2014-01-14
• Date Added to Maude: 2014-03-27
• 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: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MR. PRAVIN BETALA
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal: 49002
• Manufacturer Phone: 2693292100
• Manufacturer G1: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal Code: 49002
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 2800-000-000 35X84 P NYLA
• Generic Name: COVER, MATTRESS (MEDICAL PURPOSES
• Product Code: FMW
• Date Received: 2014-02-11
• Catalog Number: IMR000000
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Address: 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-02-11