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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARWILD CORPORATION NEURO SPONGE PATTIE; GAUZE/SPONGE INTERNAL
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CARWILD CORPORATION NEURO SPONGE PATTIE; GAUZE/SPONGE INTERNAL Back to Search Results
Catalog Number 30-058
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/07/2015
Event Type  malfunction  
Manufacturer Narrative
Investigation findings: the product is supplied to deroyal by (b)(4).(b)(4) issued.The due date is 05/13/2015.Follow up was performed (b)(4) 2015 in reference to the scar exceeding the due date.Investigation is incomplete at this time.This report will be updated as more information becomes available.
 
Event Description
The string is coming off the neuro pad causing concern that it is being left in the body as the string is not x-ray detectable.The doctor was able to retrieve the patties even though the string fell off.Again, the concern is the string was on the operating room field and is not x-ray detectable.
 
Manufacturer Narrative
Root cause analysis: part number 30-058 is supplied to deroyal industries, inc.By (b)(4).The actual product is manufactured at (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).Because there was no detection of thread attachment failures and no material changes have been made during the manufacturing process, it was determined the root cause is not the manufacturing process.The design of the product is that the string is available for location of the sponge (versus sponges without string); however, the string is not meant to be used to remove or relocate the sponge in situ (this is stated in the ifu).Therefore, (b)(4) has stated the root cause for the string detachment is usually associated with improper use of the device by using the string to relocate or remove the device.Corrective action and/or systemic action taken: in its scar response, (b)(4) has stated no correction action has been identified to be required at this time.Post-market evaluation was reviewed and no defect related to this issue was found by the end of 2014.No actions were required to be added to the risk assessment evaluation according with the post-market results specific for this type of defect.(b)(4) has indicated heightened awareness of the defect occurrence has been documented and personnel working with this product have been informed.Investigation summary an (b)(4) was received reporting that the string of a neuro pad (part number 30-058) is detaching.Because the product is supplied to deroyal, a scar was issued to the manufacturer.In its response to the scar, (b)(4) stated the device history record was reviewed for the reported lot numbers.No issues were found relating to the string detaching during the manufacturing process.In its scar response, (b)(4) indicated thread attachment is evaluated 8 pieces per sonic machine at the beginning of each work order and then each hour taken 8 pieces per the sonic machine.Thread attachment must be equal to or greater than 1.0 lb force.All data was found to be between 1.34-4.12 lbs in lot number 11a0113.All data was found between 1.33-3.9 lbs in lot number 14a0079.(b)(4).Preventive action: a preventive action is not being taken at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.
 
Event Description
The string is coming off the neuro pad causing concern that it is being left in the body as the string is not x-ray detectable.The doctor was able to retrieve the patties even though the string fell off.Again, the concern is the string was on the or field and is not x-ray detectable.
 
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Brand Name
NEURO SPONGE PATTIE
Type of Device
GAUZE/SPONGE INTERNAL
Manufacturer (Section D)
CARWILD CORPORATION
3 state pier road
new london CT 06320
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 highway 33 south
new tazewell TN 37825
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key4787350
MDR Text Key15369991
Report Number1060680-2015-00039
Device Sequence Number1
Product Code EFQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K791871
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/15/2015,01/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number30-058
Device Lot Number11A00113 14A0079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/07/2015
Event Location Hospital
Date Manufacturer Received04/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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