AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 420670

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-16 for AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 420670 manufactured by Convatec Dominican Republic Inc.

Event Text Entries

[177383613] Device 1 of 3. (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[177383614] It was reported a sample of aquacel ag scd 9*30cm was provided in place of the aquacel ag scd 9*15cm that was previously used and found out the same result occurred of the dressing not absorbing exudate. "being an occlusive dressing, it did not leak but, exudates started depositing at the end as there was no absorption and gel formation happening. " no harm was reported; however, the patient? S clothing was soiled. A video depicting the reported complaint issue was provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618003-2020-00378
MDR Report Key9597417
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-01-16
Date of Event2020-01-01
Date Mfgr Received2020-01-01
Date Added to Maude2020-01-16
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 ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1CONVATEC DOMINICAN REPUBLIC INC
Manufacturer StreetKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA
Manufacturer CitySAN CRISTOBAL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-01-16
Model Number420670
Catalog Number420670
Lot Number8B00924
Device Expiration Date2020-02-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC DOMINICAN REPUBLIC INC
Manufacturer AddressKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-16

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