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 2016-05-02 for RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502 manufactured by Teleflex Medical.
[44136393]
(b)(4). Conclusion - a conclusion code could not be chosen. The complaint was confirmed, but the root cause is unknown. Upon receipt the rechargeable led cartridge was visually examined for any signs of damage, misuse/abuse and no issues were noted. 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 beginning 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. The complaint has been confirmed. Root cause cannot be established with the current information provided. No corrective/preventative actions will be assigned. Corroding batteries could be the result of age, extreme heat and/or cold, contact with other corrosive materials. However, these are just suggested root causes and cannot be assigned to this complaint.
Patient Sequence No: 1, Text Type: N, H10
[44136394]
The customer alleges that the device failed. Battery failing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00086 |
| MDR Report Key | 5623676 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-02 |
| Date of Report | 2016-04-11 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-04-11 |
| Date Added to Maude | 2016-05-02 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| 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 | 2016-05-02 |
| Returned To Mfg | 2016-04-20 |
| Catalog Number | 0055502 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| 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 | 2016-05-02 |