* LP-800B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-14 for * LP-800B manufactured by Aadco Advanced Products.

Event Text Entries

[71072] This letter is to inform dist that, while surveying three 0. 5 mm pb thyroid shields facility has measured radiation exposure readings which exceed normal radiation exposure readings. The following table summarizes the results of radiation surveys: geiger-muller survey instrument: ludlum 14 c, background exposure reading=0. 03 mr/hr. Thyroid shield (a), lp-800b, mfr data 5/97 yielded 0. 12 mr/hr. Thyroid shield (b), lp-8015, mfr date 5/97, yielded 0/13 mr/hr, and thyroid shield (c), lp-800b, mfr date 5/97, yielded 0/14 mr/hr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1011883
• MDR Report Key: 113177
• Date Received: 1997-08-14
• Date of Report: 1997-08-04
• Date Added to Maude: 1997-08-18
• 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
• Reporter Occupation: PHYSICIST
• 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: *
• Generic Name: THYROID SHIELD A, & C
• Product Code: KPY
• Date Received: 1997-08-14
• Model Number: *
• Catalog Number: LP-800B
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 111106
• Manufacturer: AADCO ADVANCED PRODUCTS
• Manufacturer Address: RT 66, P.O. BOX 410 CATAMOUNT PARK RANDOLPH VT 05060 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: THYROID SHIELD B
• Product Code: KPY
• Date Received: 1997-08-14
• Model Number: *
• Catalog Number: LP-8015
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 111109
• Manufacturer: AADCO ADVANCED PRODUCTS
• Manufacturer Address: RT 66, P.O. BOX 410 CATAMOUNT PARK RANDOLPH VT 05060 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-08-14