BONE WAX 24X2.5G 1029754

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-23 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.

Event Text Entries

[60878500] (b)(4). Manufacturing site evaluation: samples received: 4 unopened units (each one of one different batch). Analysis and results: there are no previous complaints of any of the involved code-batches. Manufactured (b)(4) units of the batch 216034, (b)(4) units of the batch 215492, (b)(4) units of the batch 216104 and (b)(4) units of the batch 216102. There are no units in stock of any of the batches. Batch manufacturing records of the involved reference-batches have been checked and no deviations have been found. The following parameters of each sample received and other three different batches have been tested: smell, color, appearance, suppleness and adhesive behavior. All batches are into the current range for this product. No differences have been found between the different batches analyzed: the smell is the usual one, there is not smell rancid. The color is white yellow as usual. The appearance is according to the visual standard. Regarding the suppleness, the products can be kneaded well. And concerning the adhesive behavior, the product hold well on instruments. Final conclusion: complaint is not justified. Results of the samples received fulfills the oem requirements. Note is taken of this incident in order to assess if new or additional actions are needed. Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions. Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
Patient Sequence No: 1, Text Type: N, H10


[60878501] Country of complaint: (b)(6). It was reported that there is a problem with the bone wax, the product crumbles upon use. The product does not stick well to the instruments and is not effective. All med watch submissions related to this report are: 2916714-2016-00960, 2916714-2016-00961, 2916714-2016-00962.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2016-00962
MDR Report Key6125997
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-11-23
Date of Report2016-11-17
Date Facility Aware2016-11-04
Date Mfgr Received2016-10-24
Date Added to Maude2016-11-23
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 ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1B.BRAUN SURGICAL SA
Manufacturer Street121 CARRETERA DE TERRASSA
Manufacturer CityRUBI, BARCELONA 08191
Manufacturer CountrySP
Manufacturer Postal Code08191
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBONE WAX 24X2.5G
Generic NameBONE WAX
Product CodeMTJ
Date Received2016-11-23
Returned To Mfg2016-10-31
Model Number1029754
Catalog Number1029754
Lot Number216102
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB.BRAUN SURGICAL SA
Manufacturer Address121 CARRETERA DE TERRASSA RUBI, BARCELONA 08191 SP 08191


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-11-23

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