RHEIN 99IH90100 R *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-29 for RHEIN 99IH90100 R * manufactured by Rhein Medical.

Event Text Entries

[365816] Foreign body in od.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 519154
• MDR Report Key: 519154
• Date Received: 2004-03-29
• Date of Report: 2004-03-23
• Date of Event: 2003-06-03
• Date Facility Aware: 2003-06-03
• Report Date: 2004-03-23
• Date Reported to FDA: 2004-03-23
• Date Reported to Mfgr: 2004-03-23
• Date Added to Maude: 2004-04-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: RHEIN
• Generic Name: IA HANDPIECE HEX HANDLE
• Product Code: HQE
• Date Received: 2004-03-29
• Model Number: 99IH90100 R
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 508210
• Manufacturer: RHEIN MEDICAL
• Manufacturer Address: 5110 EISENHOWER BLVD SUITE 220 TAMPA FL 33634 US

Device Sequence Number: 2

• Brand Name: RHEIN
• Generic Name: ASSORTED TIPS-45 IA TIP
• Product Code: KYG
• Date Received: 2004-03-29
• Model Number: 99IH 90303
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 521809
• Manufacturer: RHEIN MEDICAL
• Manufacturer Address: 5110 EISENHOWER BLVD. STE. 220 TAMPA FL 33634 US

Device Sequence Number: 3

• Brand Name: RHEIN
• Generic Name: BINKHORST 180 IA TIP
• Product Code: KYG
• Date Received: 2004-03-29
• Model Number: 99IH 90306
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 521815
• Manufacturer: RHEIN MEDICAL
• Manufacturer Address: 5110 EISENHOWER BLVD. STE. 220 TAMPA FL 33634 US

Device Sequence Number: 4

• Brand Name: RHEIN
• Generic Name: STRAIGHT IA TIP .3MM
• Product Code: KYG
• Date Received: 2004-03-29
• Model Number: 99IH 90301
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 521817
• Manufacturer: RHEIN MEDICAL
• Manufacturer Address: 5110 EISENHOWER BLVD. STE. 220 TAMPA FL 33634 US

Device Sequence Number: 5

• Brand Name: RHEIN
• Generic Name: STRAIGHT SILICONE SLEEVE .3MM
• Product Code: KGY
• Date Received: 2004-03-29
• Model Number: 99IH 90307
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 521821
• Manufacturer: RHEIN MEDICAL
• Manufacturer Address: 5110 EISENHOWER BLVD. STE. 220 TAMPA FL 33634 US

Device Sequence Number: 6

• Brand Name: RHEIN
• Generic Name: CURVED SILICONE SLEEVE .3MM
• Product Code: KYG
• Date Received: 2004-03-29
• Model Number: 99IH 90311
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 521823
• Manufacturer: RHEIN MEDICAL
• Manufacturer Address: 5110 EISENHOWER BLVD. STE. 220 TAMPA FL 33634 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-03-29