HARH36 HARH36RR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-30 for HARH36 HARH36RR manufactured by Stryker Sustainability Solutions Lakeland.

MAUDE Entry Details

• Report Number: 0001056128-2019-00037
• MDR Report Key: 8844075
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-07-30
• Date of Report: 2019-07-30
• Date of Event: 2019-06-21
• Date Mfgr Received: 2019-07-03
• Device Manufacturer Date: 2019-02-11
• Date Added to Maude: 2019-07-30
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. MARISSA RICHMOND
• Manufacturer Street: 1810 W. DRAKE DRIVE
• Manufacturer City: TEMPE AZ 85283
• Manufacturer Country: US
• Manufacturer Postal: 85283
• Manufacturer Phone: 8888883433
• Manufacturer G1: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
• Manufacturer Street: 5300 REGION CT
• Manufacturer City: LAKELAND FL 33815
• Manufacturer Country: US
• Manufacturer Postal Code: 33815
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NA
• Generic Name: SCALPEL, ULTRASONIC, REPROCESSED
• Product Code: NLQ
• Date Received: 2019-07-30
• Returned To Mfg: 2019-07-18
• Model Number: HARH36
• Catalog Number: HARH36RR
• Lot Number: 9856384
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
• Manufacturer Address: 5300 REGION CT LAKELAND FL 33815 US 33815

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-30