MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for CAPITAL TEMP PUMP PROFESSIONAL TP700 manufactured by Stryker Medical-kalamazoo.
[134718846]
It was reported that the pad got hot and the back of the neck was red. Medical intervention was not reported.
Patient Sequence No: 1, Text Type: D, B5
[141577270]
The user facility stated that the patient complained that the pad was too hot. The patient's neck was checked and the skin was red. It was reported that it was just skin redness and no treatment or medical intervention was needed. It is unknown if the product met specifications as the product was not returned for evaluation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[141577271]
It was reported that the pad got hot and the back of the neck was red.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2019-00263 |
| MDR Report Key | 8294869 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-01-31 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPITAL TEMP PUMP PROFESSIONAL |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2019-01-31 |
| Catalog Number | TP700 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |