MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for WHITEHALL UNKNOWN manufactured by Fabricacion Y Manufacturas De Mexico S.a. De C.v..
[129348386]
A whitehall representative at a show was approached by a female attendee to tell the rep about a problem she had with a splint pan. She stated that a splint pan had "burnt up". The whitehall representative asked her if the uinit had been run dry (without water), to which she replied "no". She continued saying that the fire department had been called to the scene. She stated she order a replacement unit. No information as to if the splint pan was a whitehall unit nor was any information on the serial number or other identifying markings given. The reporter did not state that any injury or adverse event occurred.
Patient Sequence No: 1, Text Type: N, H10
[129348387]
A whitehall representative was at a show in dallas. While manning the whitehall booth, a female approached the whitehall rep about a splint pan she had an issue with. The female stated that her splint pan had burnt up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2222003-2018-00003 |
| MDR Report Key | 8114758 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-11-29 |
| 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 | MR FARHAD SHARIARY |
| Manufacturer Street | 15125 PROCTOR |
| Manufacturer City | CITY OF INDUSTRY CA 91746 |
| Manufacturer Country | US |
| Manufacturer Postal | 91746 |
| Manufacturer Phone | 6263364561 |
| Manufacturer G1 | FABRICACION Y MANUFACTURAS |
| Manufacturer Street | CALLE MAQUILADORA NO. 1387-1 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA, MEXICO 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WHITEHALL |
| Generic Name | SPLINT PAN |
| Product Code | IRQ |
| Date Received | 2018-11-29 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V. |
| Manufacturer Address | CALLE MAQUILADORAS NO. 1387-1 CUIDAD INDUSTRIAL, TIJUANA, MEXICO 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-29 |