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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFOAM® SPONGE SIZE 12-7 PRODUCT CODE 1972
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FERROSAN MEDICAL DEVICES A/S SURGIFOAM® SPONGE SIZE 12-7 PRODUCT CODE 1972 Back to Search Results
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report covers patient no.16 out of 20.Please refer to fda report no.: 3008478369-2020-00001 (internal ferrosan medical devices a/s report no.: (b)(4)) for evaluation of this event.It was reported that similar events have occurred for around 20 patients over a year span.Therefore, 20 internal reports have been done and accordingly 20 reports to fda are done.Reference numbers: fda 3008478369-2020-00001, 3008478369-2020-00003, 3008478369-2020-00004, 3008478369-2020-00005, 3008478369-2020-00006, 3008478369-2020-00007, 3008478369-2020-00008, 3008478369-2020-00009, 3008478369-2020-00010, 3008478369-2020-00011, 3008478369-2020-00012, 3008478369-2020-00013, 3008478369-2020-00014, 3008478369-2020-00015, 3008478369-2020-00016, 3008478369-2020-00018, 3008478369-2020-00019, 3008478369-2020-00020, 3008478369-2020-00021.Ferrosan medical devices a/s (b)(4).
 
Event or Problem Description
This report covers patient no.16 out of 20.Please refer to fda report no.: 3008478369-2020-00001 (internal ferrosan medical devices a/s report no.: (b)(4)) for evaluation of this event.
 
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Brand Name
SURGIFOAM® SPONGE SIZE 12-7 PRODUCT CODE 1972
Common Device Name
SURGIFOAM® SPONGE
Manufacturer (Section D)
FERROSAN MEDICAL DEVICES A/S
sydmarken 5
soeborg, 2860
DA  2860
MDR Report Key9785039
Report Number3008478369-2020-00017
Device Sequence Number19485586
Product Code LMF
UDI-Device Identifier25712123000155
UDI-Public25712123000155
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P990004
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/03/2020
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
Operator of Device Health Professional
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/17/2020
Initial Report FDA Received Date03/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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