MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-06 for GEBAUER'S SPRAY AND STRETCH 0386-0004-04 manufactured by Gebauer Co.
[28313342]
One (1) cn is not spraying as fine stream and the other can is not spraying very well at all. Nearly full can; lot 8095, exp: 12/01/2016, does not spray fine stream. Second can: about 1/2 empty lot 8094, exp: 11/01/2016, does not spray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056935 |
| MDR Report Key | 5147950 |
| Date Received | 2015-10-06 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-09-28 |
| Date Added to Maude | 2015-10-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GEBAUER'S SPRAY AND STRETCH |
| Generic Name | REFRIGERANT, TOPICAL (VAPO COOLANT) |
| Product Code | MLY |
| Date Received | 2015-10-06 |
| Catalog Number | 0386-0004-04 |
| Lot Number | 8095 |
| Device Expiration Date | 2016-12-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO |
| Brand Name | GEBAUER'S SPRAY AND STRETCH |
| Generic Name | REFRIGERANT, TOPICAL (VAPO COOLANT) |
| Product Code | MLY |
| Date Received | 2015-10-06 |
| Catalog Number | 0386-0004-04 |
| Lot Number | 8094 |
| Device Expiration Date | 2016-11-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-06 |