TENTHOUSE 10" X 10" X 8" 903050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-14 for TENTHOUSE 10" X 10" X 8" 903050 manufactured by Nova.

Event Text Entries

[2231] Neonate had foreign body lodged above pharynx. Neonate had lanynoscope procedure performed for removal of foreign body which was noted to be a clear plastic disc. Upon review, found that disc was circular punchout from nova tenthouse. Follow-up action: all plastic discs removed prior to hood being placed on patient. No instruction sheet for uses supplied by company, no signage on product regarding possible hazard. Patient tolerated procedure well and subsequently discharged home in satisfactory conditondevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: invalid data. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3660
• MDR Report Key: 3660
• Date Received: 1992-07-14
• Date of Report: 1992-06-15
• Date of Event: 1992-05-29
• Date Facility Aware: 1992-06-03
• Report Date: 1992-06-15
• Date Reported to Mfgr: 1992-06-08
• Date Added to Maude: 1993-04-29
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TENTHOUSE
• Generic Name: N/A
• Product Code: FOG
• Date Received: 1992-07-14
• Model Number: 10" X 10" X 8"
• Catalog Number: 903050
• Lot Number: 031092
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3406
• Manufacturer: NOVA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-14