MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for FAST FREEZE PAIN RELIEVING SPRAY manufactured by .
[130613271]
Patient Sequence No: 1, Text Type: N, H10
[130613272]
It was reported that a bottle of fast-freeze spray was damaged and wet; the bottle was leaking. The person who handled the bottle had to go to an emergency room because he rubbed his eyes with the spray ingredients after opening the package. The end user is experiencing pain and doctors have reportedly stated that the event led to burning of his eye nerves. The end user reports that he has to see a doctor every three weeks and takes three different eye drops four times a day. The end user states he still has serious eye problems and he has not found anything to give him relief. The product was requested for return but it is unavailable because it has been disposed. Lot number and photos were also requested but are unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2018-00009 |
| MDR Report Key | 8171847 |
| Date Received | 2018-12-17 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2018-12-17 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920819663 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FAST FREEZE PAIN RELIEVING SPRAY |
| Generic Name | MENTHOL SPRAY |
| Product Code | BRY |
| Date Received | 2018-12-17 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2018-12-17 |