HAND DRILL - STERILE INS030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-04-16 for HAND DRILL - STERILE INS030 manufactured by Integra Pain Management.

Event Text Entries

[4569757] This is the second of two reports regarding ins030 (hand drill - sterile) (same product id, different lot numbers). It was reported that there was discoloration on the inside package; there was a strain on the packaging itself. Both product were opened. The products were use when they noticed the stain. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


[11973754] To date, the device involved in the reports incident has not been received by evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1722447-2014-00009
MDR Report Key3871618
Report Source04,06
Date Received2014-04-16
Date of Report2014-03-27
Date Mfgr Received2014-03-27
Date Added to Maude2014-06-27
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 FDA0
Event Location0
Manufacturer ContactROWENA BUNUDAN
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHAND DRILL - STERILE
Generic NameNA
Product CodeHBG
Date Received2014-04-16
Catalog NumberINS030
Lot NumberW1305159
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA PAIN MANAGEMENT
Manufacturer AddressSALT LAKE CITY UT 84104 US 84104


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-16

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