MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-26 for TEMP THERAPY PAD BOX OF10 8002062026 manufactured by Stryker Medical-kalamazoo.
[143698431]
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program. 3 devices are pending evaluation. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[143698432]
This report summarizes 3 malfunction events, where it was reported the blanket was leaking at the patient site. There was patient involvement, however there were no consequences or impacts to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2019-00376 |
| MDR Report Key | 8554971 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-26 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-26 |
| 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. MARY KLAVER |
| 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 | 3 |
| Brand Name | TEMP THERAPY PAD BOX OF10 |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2019-04-26 |
| Catalog Number | 8002062026 |
| Lot Number | VMSR |
| 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 | 2019-04-26 |