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 2019-05-07 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.
[144322592]
(b)(4). Reported device not marketed in the u. S. , however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u. S. K000021. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
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The reporter indicated that there was no product inside the package. No other information has been provided.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3003639970-2019-00391 |
MDR Report Key | 8587346 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-05-07 |
Date of Report | 2019-05-23 |
Date Facility Aware | 2019-05-13 |
Date Mfgr Received | 2019-05-13 |
Date Added to Maude | 2019-05-07 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. LINDSAY CHROMIAK |
Manufacturer Street | 3773 CORPORATE PARKWAY |
Manufacturer City | CENTER VALLEY PA 18034 |
Manufacturer Country | US |
Manufacturer Postal | 18034 |
Manufacturer Phone | 8002581946 |
Manufacturer G1 | B/ BRAUN SURGICAL SA |
Manufacturer Street | 121 CARRETERA DE TERRASSA |
Manufacturer City | RUBI, 08191 |
Manufacturer Country | SP |
Manufacturer Postal Code | 08191 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BONE WAX 24X2.5G |
Generic Name | HAEMOSTYPTICS, PROPHYLAXIS OF |
Product Code | MTJ |
Date Received | 2019-05-07 |
Returned To Mfg | 2019-04-25 |
Model Number | 1029754 |
Catalog Number | 1029754 |
Lot Number | 218504 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | B.BRAUN SURGICAL SA |
Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-05-07 |