PHARMESEAL N/A 11460-0160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-28 for PHARMESEAL N/A 11460-0160 manufactured by Baxter.

Event Text Entries

[19897861] Respiratory therapist went to use hell warmer on ped patient and the bag exploded from the top of the bag and contents splashed into employees eyes. A cerified nurse practitioner's had the contents splash on to her hair and forhead did not burn her, but her clothes did receive holes in them. Other witness was not injuryed. I the risk manager could not fine dthe package it was destroyed, not saved all other heel warmers through out the hospital removed on 11/30/93. Device labeled for single use. Patient medical status prior to event: unknown. There was multiple patient involvement. Number of patients involved: 2. 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: visual examination. Results of evaluation: design - inadequate, labeling - difficult to read/see, labeling - on package, telemetry failure. Conclusion: device failure directly caused event, device discarded - unable to follow-up, device unavailable for follow-up investigation examination. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, device permanently removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7485
• MDR Report Key: 7485
• Date Received: 1994-01-28
• Date of Report: 1993-12-06
• Date of Event: 1993-11-23
• Date Facility Aware: 1993-11-23
• Report Date: 1993-12-06
• Date Reported to Mfgr: 1993-12-03
• Date Added to Maude: 1994-04-26
• 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: PHARMESEAL
• Generic Name: INFANT HEEL WARMER
• Product Code: IFS
• Date Received: 1994-01-28
• Model Number: N/A
• Catalog Number: 11460-0160
• Lot Number: LV3L150 LV3L100 LV3K172
• ID Number: PAT. NO. 3,951,127
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7166
• Manufacturer: BAXTER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-01-28