MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-01-25 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION manufactured by Genzyme Polyclonals S.a.s..
[2764730]
The pt is not doing well [complications of transplanted heart]. Case description: spontaneous report received on (b)(6) 2010, from a health care professional regarding a (b)(6) male, cardiac transplant pt, initials (b)(6). The pt received a cardiac graft that had been preserved with celsior on (b)(6) 2010. Medical history was not provided. Post-transplant, the reporter indicated "the pt is not doing well". Concomitant medication was not provided. Causality and intensity were not provided.
Patient Sequence No: 1, Text Type: D, B5
[9927362]
Manufacturer's comment: no further details were received. Further information has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220423-2010-00035 |
| MDR Report Key | 2619042 |
| Report Source | 05 |
| Date Received | 2010-01-25 |
| Date of Report | 2010-01-11 |
| Date of Event | 2010-01-10 |
| Date Mfgr Received | 2010-01-11 |
| Date Added to Maude | 2012-06-19 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WYTSKE KINGMA, MD |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 8007454447 |
| Manufacturer G1 | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Street | 58 AVENUE DEBOURG |
| Manufacturer City | LYON |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2010-01-25 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | CE215-02 |
| ID Number | UNK |
| Device Expiration Date | 2011-05-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-25 |