MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-04 for TEMP PUMP TEMPERATURE TP500C NA manufactured by Stryker Corp Dba Gaymar.
[2014432]
It was reported that the unit had a melted case. No patient involvement or adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[9129585]
Unit has not yet been returned to manufacturer for evaluation. Follow-up report will be filed if necessary based upon results of manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1313850-2011-00095 |
MDR Report Key | 2117643 |
Report Source | 06 |
Date Received | 2011-05-04 |
Date of Report | 2011-04-06 |
Date of Event | 2011-04-06 |
Date Mfgr Received | 2011-04-06 |
Device Manufacturer Date | 2008-08-15 |
Date Added to Maude | 2011-07-21 |
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 |
Health Professional | 0 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | RENATA SILA |
Manufacturer Street | 3800 EAST CENTRE AVE |
Manufacturer City | PORTAGE MI 49002 |
Manufacturer Country | US |
Manufacturer Postal | 49002 |
Manufacturer Phone | 2693896689 |
Manufacturer G1 | STRYKER CORP DBA GAYMAR |
Manufacturer Street | 10 CENTRE DR. |
Manufacturer City | ORCHARD PARK NY 14127 |
Manufacturer Country | US |
Manufacturer Postal Code | 14127 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TEMP PUMP TEMPERATURE |
Generic Name | PUMP |
Product Code | FOH |
Date Received | 2011-05-04 |
Model Number | TP500C |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER CORP DBA GAYMAR |
Manufacturer Address | ORCHARD PARK NY 14127 US 14127 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2011-05-04 |