MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-02-11 for MARTEL RECHARGEABLE BATTERY 06F21-35 manufactured by Martel Instruments.
[1717306]
On (b)(6) 2011, abbott point of care was contacted by a customer who reported that their rechargeable battery for their martel printer had burn marks on the inside packaging. They also reported that the item smells like it may have been hot during shipping. The customer did not take the battery out of the packaging. Based on the information at the time, there was no injury associated with the event.
Patient Sequence No: 1, Text Type: D, B5
[8957019]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2245578-2011-00024 |
| MDR Report Key | 2008711 |
| Report Source | 05 |
| Date Received | 2011-02-11 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-02-08 |
| Date Mfgr Received | 2011-02-08 |
| Date Added to Maude | 2012-02-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER SCOTT |
| Manufacturer Street | 400 COLLEGE ROAD EAST |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6094549270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARTEL RECHARGEABLE BATTERY |
| Generic Name | MARTEL RECHARGEABLE BATTERY |
| Product Code | FCO |
| Date Received | 2011-02-11 |
| Model Number | NA |
| Catalog Number | 06F21-35 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARTEL INSTRUMENTS |
| Manufacturer Address | DURHAM UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-11 |