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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BURLINGTON MEDICAL BURLINGTON MEDICAL; LEAD APRON

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BURLINGTON MEDICAL BURLINGTON MEDICAL; LEAD APRON Back to Search Results
Model Number KILT
Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Lutheran medical center returned this kilt front and back style protective apron with velcro closure (model kilt, manufactured 3/13/2017, serial number (b)(4)) to burlington medical on 5/14/2019 because there were two 1 x 2 inch holes in the protection material.These aprons have a 2-yr manufacturer's warranty.The apron was repaired and returned to the customer.This apron was determined to have the same condition as previously returned aprons, and was manufactured with ve25 from lot # 4703.It was noted that this lot of lead didn't feel the same as previous component material; however, the material met all inspection requirements, so it was used in the manufacture of devices designed to protect against radiation exposure.The other returned devices are referenced in the following mdrs: 1222742-2019-00001, 1222742-2019-00002, 1222742-2019-00003, 1222742-2019-00005, 1222742-2019-00006, 1222742-2019-00007, and 1222742-2019-00008.These aprons are inspected at least annually by the user-facility, and much more often by the technicians who use them.Despite this, burlington medical has decided to take a very conservative stance and recall all protective devices made with material that was noted to have slightly different properties (didn't feel the same as previous material).The total number of products to be recalled is 4,201 and the majority are thyroid shields.A 5-day mdr has been filed to capture this remedial action (mdr 1222742-2019-00009).
 
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Brand Name
BURLINGTON MEDICAL
Type of Device
LEAD APRON
Manufacturer (Section D)
BURLINGTON MEDICAL
7 elmhurst st.
newport news VA 23603
Manufacturer (Section G)
BURLINGTON MEDICAL
7 elmhurst st
newport news VA 23603
Manufacturer Contact
john daspit
7 elmhurst dr
newport news, VA 23603
7579685846
MDR Report Key8693070
MDR Text Key207716005
Report Number1222742-2019-00004
Device Sequence Number1
Product Code EAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510(K)EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Remedial Action Recall
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberKILT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/14/2019
Initial Date FDA Received06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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