MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for ELASTOGEL HYPOTHERMIA MITTS TM7008 manufactured by Southwest Technologies, Inc..
[124660855]
No information was given as to the lot number of the product used. The lot number references the production date or a close proximity of the date of production. The product used does not carry an expiration date.
Patient Sequence No: 1, Text Type: N, H10
[124660856]
On (b)(6) 2017, a patient called to report an adverse event while using the hypothermia mitts she purchased on (b)(6) 2017. She said she got frostbite on 3 fingers and will be losing all 3 fingers due to frostbite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929833-2018-00002 |
| MDR Report Key | 7992583 |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-19 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2018-10-22 |
| 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 Street | 1746 LEVEE RD. |
| Manufacturer City | NORTH KANSAS CITY MO 64116 |
| Manufacturer Country | US |
| Manufacturer Postal | 64116 |
| Manufacturer Phone | 8162212442 |
| Manufacturer G1 | SOUTHWEST TECHNOLOGIES, INC. |
| Manufacturer Street | 1746 LEVEE RD. |
| Manufacturer City | NORTH KANSAS CITY MO 64116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELASTOGEL HYPOTHERMIA MITTS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2018-10-22 |
| Model Number | TM7008 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHWEST TECHNOLOGIES, INC. |
| Manufacturer Address | 1746 LEVEE RD. NORTH KANSAS CITY MO 64116 US 64116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-22 |