MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-06-12 for NICD BATTERY PACK 6500700006 NA manufactured by Stryker Medical.
[2730069]
It was reported that a dewalt battery was smoking while sitting in a box. There was no pt involvement or adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[9919979]
Unit was evaluated by the customer. Manufacturer's investigation is still ongoing; if additional info is received, a follow-up report may be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1831750-2012-06269 |
| MDR Report Key | 2621733 |
| Report Source | 06,07 |
| Date Received | 2012-06-12 |
| Date of Report | 2012-05-14 |
| Date of Event | 2012-05-14 |
| Date Mfgr Received | 2012-05-14 |
| Date Added to Maude | 2012-06-22 |
| 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 E. CENTRE AVE. |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693896689 |
| Manufacturer G1 | STRYKER MEDICAL |
| Manufacturer Street | 3800 E. CENTRE AVE. |
| 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 | NICD BATTERY PACK |
| Generic Name | BATTERY |
| Product Code | FCO |
| Date Received | 2012-06-12 |
| Model Number | 6500700006 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-12 |