MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-03 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments-kalamazoo.
[3162383]
It was reported that the castvac w/8 foot hose and mobile stand was allegedly overheating during a procedure. The procedure was completed successfully without any delay. There was no medical treatment or intervention required as a result of the event and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[3718847]
It was reported that the castvac w/8 foot hose and mobile stand was allegedly overheating during a procedure. The procedure was completed successfully without any delay. There was no medical treatment or intervention required as a result of the event and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[10830476]
The device is available for evaluation but has not yet been received. Additional information may be submitted once the device is received and the quality investigation is complete. The device is available for evaluation but has not yet been received. Additional information will be submitted once the device is received and the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[11227460]
The product was not returned for evaluation, so the reported event of overheating could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[20980103]
It was reported that the castvac w/8 foot hose and mobile stand was overheating during a procedure. The procedure was completed successfully without any delay. There was no medical treatment or intervention required as a result of the event and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[21298914]
There was no patient or user injury as a result of this event and reported information regarding this event does not suggest a recurrence of this event would result in a serious injury. Cast vac does not come in direct contact with user or the patient. There was no indication of smoke, flames, or sparks associated with this event. In the past, this type of malfunction for this product has not caused or contributed to a death or serious injury. This is not a fileable event; the report was filed in error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-01022 |
| MDR Report Key | 3092181 |
| Report Source | 06 |
| Date Received | 2013-05-03 |
| Date of Report | 2013-04-29 |
| Date of Event | 2013-04-29 |
| Date Mfgr Received | 2014-04-21 |
| Date Added to Maude | 2013-07-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASTVAC W/8 FOOT HOSE AND MOBILE STAND |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2013-05-03 |
| Catalog Number | 0986000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-03 |