DUOLOCK TAIL CLSR CURVED TAN SRA8280

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-03-25 for DUOLOCK TAIL CLSR CURVED TAN SRA8280 manufactured by Convatec Limited.

Event Text Entries

[41218119] Expiration date: 05/2020. Manufacturing date: 05/2015. Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Note: two cases associated with this complaint. A separate fda form 3500a has been completed for the unknown number of affected products with multiple possible lots numbers associated with this complaint. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[41218120] It was reported by the end user that the tail clips dig and irritate her flesh in the area of the abdomen where the clip rests/digs in. It was also reported that this has occurred with other similar products for years.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000317571-2016-00031
MDR Report Key5527245
Report SourceCONSUMER
Date Received2016-03-25
Date of Report2016-03-02
Date Mfgr Received2016-03-02
Date Added to Maude2016-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDUOLOCK TAIL CLSR CURVED TAN
Generic NameAPPLIANCE, COLOSTOMY, DISPOSABLE
Product CodeEZS
Date Received2016-03-25
Model NumberSRA8280
Lot Number5E03205
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC LIMITED
Manufacturer AddressFIRST AVENUE DEESIDE INDUSTRICAL PARK DEESIDE, FLINSHIRE CH52NU UK CH52NU


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-25

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