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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD BIOSORB¿ GELLING FIBER DRESSING; NAD
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SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD BIOSORB¿ GELLING FIBER DRESSING; NAD Back to Search Results
Model Number BIOGFD
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Abscess (1690); Foreign Body In Patient (2687)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, it cannot be determined that the abscess is related to the biosorb¿ gelling fiber dressing.It is unknown when the foreign material alleged to be biosorb¿ gelling fiber dressing was placed in the wound.A device evaluation of lot number 1807/3/1/1 is currently pending completion.Device labeling, available in print states: dressing change or removal: the dressing should be changed when medically indicated (e.G.When the dressing has reached its absorbent capacity or when good wound care practices dictates a change is needed).The interval between changes should be no more that 7 days.Should the dressing adhere to wounds with lower exudate levels, moisten it with sterile physiological saline solution (0.9%) before changing the dressing so that the healing process is not disturbed.Any gel residue on the wound should be removed when cleansing the wound.Deep wounds in particular should be well irrigated.
 
Event Description
On 16-jan-2019, the following information was reported to kci by the pharmacist: 55 mm gauze, non kci or systagenix product, with biosorb¿ gelling fiber dressing lot number 1807/3/1/1 allegedly caused a foot ulcer in the wound of a diabetic after it was removed.During yesterday's dressing [(b)(6) 2019], a subcutaneous abscess was caused by the gauze staying in place despite it being removed and the wound being cleaned.The gauze could not be completely removed owing to breakdown of the product.Proven consequences: abscess in the wound infected with multi-sensitive escherichia coli which required surgical removal.On 21-jan-2019, the following information was reported to kci by the pharmacist: during the first dressing, the dressing allegedly disintegrated and as a result, the patient developed a deep abscess.On (b)(6) 2018, a culture was performed.On (b)(6) 2018, the patient underwent a surgical cleaning in the operating room.The patient was placed on antibiotic treatment and has progressed favorably.A device history review of lot number 1807/3/1/1 determined that there were no nonconformances identified nor deviations used during the manufacture of this lot.All end release testing of product and packaging met specifications.A device evaluation of lot number 1807/3/1/1 is currently pending completion.
 
Manufacturer Narrative
Mdr-3007663067-2019-00001 submitted on 15-feb-2019.Date of event: (b)(6) 2019.Correction: date of event (b)(6) 2018.Additional device information-catalog number bgf0245f was added.Based on the additional information obtained regarding the biosorb¿ gelling fiber dressing, kci's assessment remains the same; it cannot be determined that the abscess is related to the biosorb¿ gelling fiber dressing.
 
Event Description
A device evaluation of lot number 1807/3/1/1 determined on 24-jan-2019, systagenix quality received 1 carton of biosorb¿ gelling fiber dressing.On 12-mar-2019, systagenix quality determined the returned biosorb¿ gelling fiber dressing and batch records from the same lot 1807/3/1/1 were examined by the manufacturer.The review determined there were no concerns associated with the manufacturing process and this lot met the release criteria.
 
Manufacturer Narrative
Mdr-3007663067-2019-00001 submitted on 15-feb-2019.Date of event: (b)(6) 2019.Correction: date of event (b)(6) 2018.Additional device information-catalog number bgf0245f was added.Based on the additional information obtained regarding the biosorb¿ gelling fiber dressing, kci's assessment remains the same; it cannot be determined that the abscess is related to the biosorb¿ gelling fiber dressing.
 
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Brand Name
BIOSORB¿ GELLING FIBER DRESSING
Type of Device
NAD
Manufacturer (Section D)
SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD
gargrave
north yorkshire, england BD23 3RX
UK  BD23 3RX
MDR Report Key8344153
MDR Text Key136289798
Report Number3007663067-2019-00001
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Model NumberBIOGFD
Device Catalogue NumberBGF0245F
Device Lot Number1807/3/1/1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Initial Date Manufacturer Received 01/16/2019
Initial Date FDA Received02/15/2019
Supplement Dates Manufacturer Received01/16/2019
Supplement Dates FDA Received03/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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