MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for RBX manufactured by Sun Pharmaceutical Industries Ltd..
[112896784]
I had a small cut in my right foot. I bought a rbx first aid bandage marketed by sun pharma and formerly product of erstwhile ranbaxy laboratories, ltd. When the pack was peeled off, 50 percent of the product was torn or missing. Poor quality product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078152 |
| MDR Report Key | 7650267 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-17 |
| Date of Event | 2018-06-17 |
| Date Added to Maude | 2018-06-29 |
| 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 | PATIENT |
| 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 | RBX |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-06-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUN PHARMACEUTICAL INDUSTRIES LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |