MEDLINE FOG INHIBITOR WITH SPONGE NONFB100 MD-1001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for MEDLINE FOG INHIBITOR WITH SPONGE NONFB100 MD-1001 manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[113636142] No further information is available on the product at this time. The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[113636143] Aspen surgical received a report from the distributor indicating that the product was found in the seal of a pouch. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2018-00078
MDR Report Key7665833
Date Received2018-07-06
Date of Report2018-06-07
Date of Event2018-06-07
Date Mfgr Received2018-06-07
Device Manufacturer Date2018-02-13
Date Added to Maude2018-07-06
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 NameMEDLINE FOG INHIBITOR WITH SPONGE NONFB100
Generic NameANTI-FOG
Product CodeOCT
Date Received2018-07-06
Model NumberMD-1001
Lot Number155885
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 2018-07-06

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