MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-09-20 for BIAFINE manufactured by Johnson And Johnson Group Of Consumer Companies.
[1753035]
This was a regulatory authority report received on 09-sep-2010 from the (b)(6) for biafine (trolamine) from (b)(6), which is marketed as biafine in the united states. The (b)(6) pregnant female consumer used two applications of biafine (trolamine) per day for seven days beginning on (b)(6) 2009 for a burn. On (b)(6) 2010, she delivered a baby girl who apparently was in good health (apgar score at 1 and at 10 after five minutes, no transfer to the intensive care unit, no malformation, no neonatal pathology). On an unspecified date two months after birth, the baby was suspected of an axial hypotonia. On an unspecified date, six months after birth, the baby did not react against visual stimuli. A blindness was surely suspected. On an unspecified date, in (b)(6) 2010, lab test showed cerebral mri was normal. Electroretinography and a visual potential test were scheduled (no further info provided). On (b)(6) 2010, the mother discontinued product use. As of (b)(6) 2010, the outcome of the event was reported as not resolved. This report is serious (disability). Baby case is linked to mother case (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8744557]
At this time, the device has not been returned for failure analysis/laboratory testing. Given the circumstances of the reported event(s) and the known mechanism of action of the device. A casual association with the device is possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002707994-2010-00002 |
| MDR Report Key | 1884144 |
| Report Source | 01,05 |
| Date Received | 2010-09-20 |
| Date of Report | 2010-09-09 |
| Date of Event | 2010-04-01 |
| Date Mfgr Received | 2010-09-09 |
| Date Added to Maude | 2010-10-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 185 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 2153257685 |
| 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 | 2010-09-20 |
| 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 AND JOHNSON GROUP OF CONSUMER COMPANIES |
| Manufacturer Address | MORRIS PLAINS NJ 07950 US 07950 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-09-20 |