UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-09 for UNK manufactured by Picker International, Inc..

Event Text Entries

[87206] In response to fda public hlth notice issued 13 june 1997 regarding radioactive contamination present in radiation protection devices, please be advised that facility purchased three (3) lead aprons from picker corp that were subsequently determined to be among the contaminated garments. Surface survey meter readings on these garments were in the range of 0. 5-1. 0 mr/hr as reported by other observers. Two of the garments were returned to the mfr in november 1997 following the product recall notification. The third was only recently discovered, is now out of svc in rptr's possession and awaits recall shipping forms from the mfr. No unusual dosimetry badge exposures were noted during the period that the garments were in svc. Worst case calculations of probable wear indicate no potential for personnel exposures in excess of the hosp's alara level i threshold.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012771
• MDR Report Key: 143294
• Date Received: 1998-01-09
• Date of Report: 1998-01-09
• Date Added to Maude: 1998-01-14
• Event Key: 0
• Report Source Code: Voluntary 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: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: UNK
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-01-09
• Model Number: NA
• Catalog Number: NI
• Lot Number: NI
• ID Number: 256255
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 139767
• Manufacturer: PICKER INTERNATIONAL, INC.
• Manufacturer Address: 595 MINER RD. HIGHLAND HGTS. OH 44143 US

Device Sequence Number: 2

• Brand Name: UNK
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-01-09
• Model Number: NA
• Catalog Number: NI
• Lot Number: NI
• ID Number: 256261
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 139768
• Manufacturer: PICKER INTERNATIONAL, INC.
• Manufacturer Address: 595 MINER RD. HIGHLAND HGTS. OH 44143 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-01-09