MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-04-26 for RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502 manufactured by Teleflex Medical.
[43688270]
Qn#(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[43688271]
The customer alleges that the device failed.
Patient Sequence No: 1, Text Type: D, B5
[44725297]
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. An attempt was made to charge the cartridge with the charging unit that is shipped in the kit with the handle and led cartridge. The red glowing charging light would not energize. The cartridge was destructively inspected. Visual signs of corrosion were found on top of the lithium-ion battery and the small led electronic driving module. The complaint has been confirmed. The lithium-ion battery leaked causing destructive corrosion inside the led cartridge housing that prevented the battery from charging. Corroding batteries could be the result of age, extreme heat and/or cold, or contact with other corrosive materials. A root cause for the issue could not be determined. A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[44725298]
The customer alleges that the device failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00085 |
| MDR Report Key | 5609337 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-11 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-05-06 |
| Date Added to Maude | 2016-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH TRULED ADULT RECHARGEABLE BATTERY |
| Generic Name | BATTERY, RECHARGEABLE |
| Product Code | FCO |
| Date Received | 2016-04-26 |
| Returned To Mfg | 2016-04-20 |
| Catalog Number | 0055502 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-26 |