CARDINAL SKIN CLOSURE, REINFORCED, 1/2" X 4", STERILE 1047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for CARDINAL SKIN CLOSURE, REINFORCED, 1/2" X 4", STERILE 1047 manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[85616833] Investigation in process. Follow up report will be submitted once complete.
Patient Sequence No: 1, Text Type: N, H10


[85616834] Compromised sterility - sterile barrier breached - description summary: found 3ea of s1047 that had a steri strips out the side, compromising the seal for sterilization.
Patient Sequence No: 1, Text Type: D, B5


[119982068] Unable to locate sample.
Patient Sequence No: 1, Text Type: N, H10


[119982089] Compromised sterility - sterile barrier breached - description summary: found 3ea of s1047 that had a steri strips out the side, compromising the seal for sterilization.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2017-00090
MDR Report Key6844473
Date Received2017-09-06
Date of Report2017-09-22
Date of Event2017-08-02
Date Mfgr Received2017-08-09
Date Added to Maude2017-09-06
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 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 NameCARDINAL SKIN CLOSURE, REINFORCED, 1/2" X 4", STERILE
Generic NameSKIN CLOSURE
Product CodeFPX
Date Received2017-09-06
Returned To Mfg2017-08-15
Model Number1047
Lot Number130016
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
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 2017-09-06

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