MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-28 for CRYOMACS FREEZING BAGS 50 N/A 200-074-400 manufactured by Miltenyi Biotec Gmbh.
[74092076]
Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[74092077]
The customer complained on a leak which had been observed in the eva tube of a cryomacs? Freezing bag 50 after sealing procedure performed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005290010-2017-00015 |
MDR Report Key | 6529622 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2017-04-28 |
Date of Report | 2017-04-26 |
Date of Event | 2017-03-31 |
Date Mfgr Received | 2017-04-03 |
Device Manufacturer Date | 2016-01-08 |
Date Added to Maude | 2017-04-28 |
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 NANCY JOHANSEN |
Manufacturer Street | 120 BEACON ST SUITE 200 |
Manufacturer City | SOMERVILLE MA 02143 |
Manufacturer Country | US |
Manufacturer Postal | 02143 |
Manufacturer Phone | 6172180062 |
Manufacturer G1 | MILTENYI BIOTEC GMBH |
Manufacturer Street | FRIEDRICH-EBERT-STRASSE 68 |
Manufacturer City | BERGISCH GLADBACH, 51429 |
Manufacturer Country | GM |
Manufacturer Postal Code | 51429 |
Single Use | 3 |
Remedial Action | NO |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CRYOMACS FREEZING BAGS 50 |
Generic Name | CRYOMACS FREEZING BAGS 50 |
Product Code | LPZ |
Date Received | 2017-04-28 |
Model Number | N/A |
Catalog Number | 200-074-400 |
Lot Number | 6151002003 |
Device Expiration Date | 2018-09-02 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MILTENYI BIOTEC GMBH |
Manufacturer Address | FRIEDRICH-EBERT-STRASSE 68 BERGISCH GLADBACH, 51429 GM 51429 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-04-28 |