MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-08-04 for BIAFINE (US) UNK manufactured by Johnson & Johnson Consumer Companies, Inc.
[1997150]
This was a spontaneous report from a health professional, via a regulatory authority (b)(6), and concerns a (b)(6) female from (b)(6). The pt's height, weight and medical history were unspecified. The pt was treated with trolamine (emulsion, topical) initiated on (b)(6) 2011 to (b)(6) 2011 for redness after being out in the mountains. Concomitant medications included logiflox (lomefloxacin) (tablet, oral) two tablets on (b)(6) 2011 and one tablet on (b)(6) 2011 for an unspecified indication. On (b)(6) 2011, the pt experienced burns at 1st and 2nd degrees on the arms, legs and upper side of the body. The pt went to the emergency unit on (b)(6) 2011 and was admitted to the hospital that same day (discharge date unspecified). Treatment was not specified. Action taken with trolamine was withdrawn. At the time of the reporting, the outcome for burn was unspecified. This case is linked to drug/device case (b)(4). This report was serious (hospitalization).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002707994-2011-00387 |
| MDR Report Key | 2196875 |
| Report Source | 01,05 |
| Date Received | 2011-08-04 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-06-22 |
| Date Mfgr Received | 2011-07-20 |
| Date Added to Maude | 2011-08-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 5760 WEST 96TH STREET |
| Manufacturer City | LOS ANGELES CA 90045 |
| Manufacturer Country | US |
| Manufacturer Postal | 90045 |
| Manufacturer Phone | 2153257722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIAFINE (US) |
| Generic Name | NONE |
| Product Code | MGQ |
| Date Received | 2011-08-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER COMPANIES, INC |
| Manufacturer Address | SKILLMAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-08-04 |