MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-29 for THERAPY LOTION * NMA-L005 manufactured by Integrated Medical, Inc..
[131957]
Rptr's facility received a case of therapy lotion consisting of 45 liter bottles. The problem is that the individual bottles have no labels whatsoever. It is unknown if this was a fluke with this batch, or if this is the standard way of packaging this product. The external box that the bottles came in did have a label, but due to the size of the bottles, the users seldom keep the bottles in the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016207 |
| MDR Report Key | 221262 |
| Date Received | 1999-04-29 |
| Date of Report | 1999-04-29 |
| Date Added to Maude | 1999-05-04 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERAPY LOTION |
| Generic Name | CONTACT MEDIUM FOR ULTRASOUND TRANSMISSION & MASSAGE THERAPY |
| Product Code | MUI |
| Date Received | 1999-04-29 |
| Model Number | * |
| Catalog Number | NMA-L005 |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214563 |
| Manufacturer | INTEGRATED MEDICAL, INC. |
| Manufacturer Address | 8100 S. AKRON #320 ENGLEWOOD CO 80112 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-29 |