DEROYAL ARM SLING ER9901-05

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 1999-08-26 for DEROYAL ARM SLING ER9901-05 manufactured by Deroyal Industries, Inc..

Event Text Entries

[15031173] Arm sling had been applied to pt. Pt attempted to adjust sling, and the sling came undone. The pt's arm flopped down. The pt's arm was partially supported by the nurse at the time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1037420-1999-00001
• MDR Report Key: 238307
• Report Source: 06
• Date Received: 1999-08-26
• Date of Report: 1999-08-26
• Date of Event: 1999-07-14
• Date Facility Aware: 1999-07-14
• Report Date: 1999-08-26
• Date Reported to FDA: 1999-08-26
• Date Mfgr Received: 1999-07-29
• Date Added to Maude: 1999-09-03
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DEROYAL ARM SLING
• Generic Name: ARM SLING
• Product Code: ILI
• Date Received: 1999-08-26
• Model Number: NA
• Catalog Number: ER9901-05
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 230941
• Manufacturer: DEROYAL INDUSTRIES, INC.
• Manufacturer Address: 200 DEBUSK LANE POWELL TN 37849 US
• Baseline Brand Name: DEROYAL ARM SLING
• Baseline Generic Name: ARM SLING
• Baseline Model No: NA
• Baseline Catalog No: ER9901-05
• Baseline ID: NA
• Baseline Device Family: ARM SLING
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-08-26
2	0		1999-08-26