OP-1 IMPLANT 10025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-20 for OP-1 IMPLANT 10025 manufactured by Olympus Biotech.

Event Text Entries

[3130041] On (b)(6) 2013, olympus biotech pvg received a report of an adverse event in a female pt (initial cd, dob (b)(6)1942) who received one unit of op-1 implant on (b)(6) 2013, as part of a procedure to treat a clavicular nonunion. Approx three days postoperatively the pt reported to her physician that she was experiencing redness and swelling at the surgical site and surrounding area. Five days postoperatively the pt was seen by the surgeon, who reported 'redness, swelling, tightness and skin irritation' at the surgery site and surrounding area, with 'more swelling than what he would have expected'. Additional info has been requested from the surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1224732-2013-00001
MDR Report Key2977915
Report Source05
Date Received2013-02-20
Date of Report2013-01-28
Date of Event2013-01-19
Date Mfgr Received2013-01-28
Date Added to Maude2013-02-28
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 Street35 SOUTH ST.
Manufacturer CityHOPKINTON MA 01748
Manufacturer CountryUS
Manufacturer Postal01748
Manufacturer Phone5084165200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOP-1 IMPLANT
Generic NameNONE
Product CodeMPW
Date Received2013-02-20
Catalog Number10025
Lot NumberFC1212001
Device Expiration Date2013-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS BIOTECH
Manufacturer AddressHOPKINTON MA 01748 US 01748


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-20

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