DURODERM CGF DRESSING 187661

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-09-25 for DURODERM CGF DRESSING 187661 manufactured by Convatec, Inc..

Event Text Entries

[3902922] (b)(6) requested a report from boston medical care because a patient was re-hospitalized due to over infection of a wound. Boston medical care responded to (b)(6) with the following statement (translated version): the patient was originally assessed on (b)(4) at clinic where they were hospitalized for 1 month. During the hospitalization, according to the history report, the patient had a surgical debridement and treatment with antibiotics was initiated. It is important to note that the vital signs reported on (b)(6) on the clinical history was: temperature 37. 8 degree celsius, bp 89/55, fc 105. The next visits were made at home on (b)(6). The last visit that was made at home, the patient was found with a regular condition, bedridden, drowsy, accompanied by caregiver (son). Ulcers assessed found were: left trochanter wound with 70% granulation, 30% fibrin, macerated edge, highly exudative, exudate serous characteristic diameter 7x4 cm, uneven edges. Management begins with duoderm gel 30 g and duoderm cgf 15x15. Right trochanter wound with 100% wet necrotic tissue, deep but could not be assessed due to the necrotic tissue that covered all the wound bedding, edge villas, moderate exudate. Management begins with aquacel ag 10x10. Left heel wound with 30% granulation, 70% of fibrin, edge macerated, moderate exudate. Management begins with duoderm gel and duoderm cgf. Patient was without signs of infection, exudate observed at the last visit is characteristic of wound treated with these hydrocolloids. After washing the wound with plenty of saline, there was no clear sings of infection. Even with background of the hospitalization and conditions of injury, don't discontinue. The patient will continue with their infectious process or at least with a critical colonization, masked by the necrotic tissue. The caregiver did not report support with antibiotics after leaving the clinic. It was mentioned to the caregiver the importance of position changes and measures to manage pressure ulcers in order to improve them. It was noticed that there is not a caregiver permanently and this depends on patient's children according to their availability. During the next visit on (b)(6), the patient was hospitalized. As described above, we consider that the patient left his hospitalization with active infectious process.
Patient Sequence No: 1, Text Type: D, B5


[11282302] Based on the available information, this event is deemed a serious injury. From a preliminary clinical perspective, a causal relationship between the device and this event is deemed unlikely as patient already had a poor medical history, had undergone a debridement (removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue) and had been placed on antibiotics before the use of the duoderm dressing product. No additional patient/ event details have been provided to date. Reported to fda on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1049092-2013-00047
MDR Report Key3403196
Report Source01,05,06,07
Date Received2013-09-25
Date of Report2013-08-27
Date of Event2013-08-22
Date Mfgr Received2013-08-27
Date Added to Maude2013-10-11
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 FDA0
Event Location0
Manufacturer ContactMARY SZARO
Manufacturer Street200 HEADQUARTERS PARK DR.
Manufacturer CitySKILLMAN NJ 08558
Manufacturer CountryUS
Manufacturer Postal08558
Manufacturer Phone9089042450
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURODERM CGF DRESSING
Generic NameOCCLUSIVE WOUND DRESSINGS
Product CodeMGP
Date Received2013-09-25
Model Number187661
Catalog Number187661
Lot Number2K01554
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC, INC.
Manufacturer Address211 AMERICAN AVE. GREENSBORO NC 27409 US 27409


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2013-09-25

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