MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-07-23 for BIAFINE manufactured by Johnson & Johnson Group Of Consumer Companies.
[2678281]
This was a regulatory authority report received on (b)(6) 2009, from (b)(6). A physician reported that a (b)(6) male used one application of biafine (trolamine) (company drug) (frequency of use unspecified) in (b)(6) 2008 (exact date unspecified), for first and second degree burns along with an unspecified amount of local corticosteroids for erythema and betadine (povidone iodine) as an antiseptic (non-company drugs) (exact frequencies, and therapy dates unspecified). In (b)(6) 2008, the pt had exanthema and eczematous medicamentous eruption. The pt was hospitalized on the same date; several cutaneous test were performed and revealed that the pt had sensitivity for biafine (trolamine) and cetyl-stearylic which is an alcohol present in a lot of local corticosteroids composition and a negative result for betadine (povidone iodine). The use of the product biafine was discontinued on (b)(6) 2008 and it is unk if product use of local corticosteroids and betadine was continued. The outcome of the events were reported as resolved in (b)(6) 2008 (exact date unspecified). This case is serious (hospitalization).
Patient Sequence No: 1, Text Type: D, B5
[9937379]
The product was not returned for failure analysis/lab testing. It cannot be ruled out that the product may have possibly caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243656-2009-00002 |
| MDR Report Key | 2609579 |
| Report Source | 01,05 |
| Date Received | 2009-07-23 |
| Date of Event | 2008-11-01 |
| Date Mfgr Received | 2009-07-07 |
| Date Added to Maude | 2012-06-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 185 TABOR RD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733852990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIAFINE |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGQ |
| Date Received | 2009-07-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON GROUP OF CONSUMER COMPANIES |
| Manufacturer Address | MORRIS PLAINS NJ 07950 US 07950 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-07-23 |