SURGICAL TUBING 0036550

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-23 for SURGICAL TUBING 0036550 manufactured by Consolidated Medical Equipment.

Event Text Entries

[145919058] The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10


[145919059] The distributor in (b)(6) rejected this product, 0036550, due to an insufficient heat seal. In this instance, there was no patient involvement as the packaging anomaly was discovered during incoming inspection prior to distribution to an end user. This report is being raised on the basis of device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007305485-2019-00159
MDR Report Key8635702
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-05-23
Date of Report2019-07-18
Date of Event2019-04-25
Date Mfgr Received2019-07-15
Device Manufacturer Date2018-05-04
Date Added to Maude2019-05-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMELANIE HANSEN
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995209
Manufacturer G1CONSOLIDATED MEDICAL EQUIPMENT
Manufacturer StreetALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA
Manufacturer City31136
Manufacturer CountryMX
Manufacturer Postal Code31136
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICAL TUBING
Generic NameSURGICAL TUBING
Product CodeBYY
Date Received2019-05-23
Returned To Mfg2019-05-28
Catalog Number0036550
Lot Number201805045
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCONSOLIDATED MEDICAL EQUIPMENT
Manufacturer AddressALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA 31136 MX 31136


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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