DR FOG TREATED SPONGE, STERILE DF-3120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for DR FOG TREATED SPONGE, STERILE DF-3120 manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[137731981] No further information is available on the product at this time. Device was not returned. However, if device becomes available and any additional relevant information is identified following completion of the evaluation, the additional relevant information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[137731982] Aspen surgical received a report from the distributor indicating that a dr fog sponge was discovered with a seal issue. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system as number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2019-00008
MDR Report Key8315174
Date Received2019-02-07
Date of Report2019-01-10
Date of Event2018-12-06
Date Mfgr Received2019-01-10
Date Added to Maude2019-02-07
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 ContactMR. JORDAN HACKERT
Manufacturer Street6945 SOUTHBELT DR. S.E.
Manufacturer CityCALEDONIA MI 49316
Manufacturer CountryUS
Manufacturer Postal49316
Manufacturer Phone6165367508
Manufacturer G1SAME AS ABOVE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDR FOG TREATED SPONGE, STERILE
Generic NameANTI-FOG
Product CodeOCT
Date Received2019-02-07
Model NumberDF-3120
Lot Number167349
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer Address6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-07

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