PERFORATED LEFT THERMOPLASTIC SPLINT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-02 for PERFORATED LEFT THERMOPLASTIC SPLINT manufactured by North Coast Medical, Inc..

Event Text Entries

[2223] Child had perforated left thermoplastic hand splint fitted over stockinette on 4/20/92. Skin irritation developed by 4/22/92. Became progressively worse by 4/24/92 and child referred to pedfiatrician. Allergic reaction to the thermoplastic splint diagnosed and splint discontinued. Pediatrician debrided macerated skin of hand. By 4/27/. 92, child developed hand hyperhydrosis. Hand has completely healeddevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding 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, visual examination. Results of evaluation: unanticipated adverse reaction - short term. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3873
• MDR Report Key: 3873
• Date Received: 1993-02-02
• Date of Report: 1992-08-17
• Date of Event: 1992-04-20
• Date Facility Aware: 1992-04-24
• Report Date: 1992-08-17
• Date Reported to FDA: 1992-08-17
• Date Reported to Mfgr: 1992-08-17
• Date Added to Maude: 1993-05-07
• 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: 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: PERFORATED LEFT THERMOPLASTIC SPLINT
• Generic Name: THERMOPLASTIC SPLINT
• Product Code: ILH
• Date Received: 1993-02-02
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3613
• Manufacturer: NORTH COAST MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-02-02