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 2017-07-20 for DR FOG TREATED SPONGE, STERILE DF-3120 manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[80757080] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[80757081] Customer reported on (b)(6) that 2 pcs had a packing failure.
Patient Sequence No: 1, Text Type: D, B5


[120298343] Operator error due to aspen's manual loading process of product into recessed pockets on the ffs machines by operators. Device not returned, picture provided.
Patient Sequence No: 1, Text Type: N, H10


[120298344] Customer reported on (b)(6) 2015 that 2 pcs had a packing failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2017-00073
MDR Report Key6730054
Date Received2017-07-20
Date of Report2017-08-04
Date of Event2017-06-01
Date Mfgr Received2017-06-22
Date Added to Maude2017-07-20
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 ContactMRS. MEGAN MORRISSEY
Manufacturer Street6945 SOUTHBELT DR. S.E.
Manufacturer CityCALEDONIA MI 49316
Manufacturer CountryUS
Manufacturer Postal49316
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 Received2017-07-20
Model NumberDF-3120
Lot Number124814
Device AvailabilityN
Device AgeDA
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 2017-07-20

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