MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-05 for WHITEHALL MANUFACTURING TT-101 manufactured by Whitehall Manufacturing.
[110197174]
Evaluation of the returned unit was performed in whitehall's r&d lab on 4/14/2014. The evaluation found that the unit had been opened by an unknown person and was modified as it was no longer assembled per manufacturing standards which may have caused the malfunction. Device was scrapped after evaluation. No additional verification of the malfunction can be performed.
Patient Sequence No: 1, Text Type: N, H10
[110197175]
Customer called whitehall field service to report that their tt-101, thermotherapy unit was showing a temperature of 200 degrees f as well as producing smoke. The customer removed the unit from service upon finding the malfunction. Whitehall replaced the unit at no charge and brought the unit in question back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000150265-2018-00001 |
| MDR Report Key | 7571726 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-05 |
| Date of Report | 2018-02-07 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2014-04-14 |
| Device Manufacturer Date | 2013-06-14 |
| Date Added to Maude | 2018-06-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DALE BARBER |
| Manufacturer Street | 15125 PROCTOR AVE |
| Manufacturer City | CITY OF INDUSTRY CA 91746 |
| Manufacturer Country | US |
| Manufacturer Postal | 91746 |
| Manufacturer Phone | 6263364561 |
| Manufacturer G1 | WHITEHALL MANUFACTURING |
| Manufacturer Street | 15125 PROCTOR AVE |
| Manufacturer City | COTY OF INDUSTRY CA 91746 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91746 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHITEHALL MANUFACTURING |
| Generic Name | THERMO-THERAPY |
| Product Code | LSB |
| Date Received | 2018-06-05 |
| Model Number | TT-101 |
| Catalog Number | TT-101 |
| Lot Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WHITEHALL MANUFACTURING |
| Manufacturer Address | 15125 PROCTOR AVE CITY OF INDUSTRY CA 91746 US 91746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |