MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-28 for NEOSPORIN SCAR SOLUTION * manufactured by Johnson & Johnson Group Of Consumer Cos..
[20514040]
A pregnant female consumer reported using one neosporin scar solution sheet (silicone) daily beginning on an unk date in 2005 to reduce the appearance of a scar. Her expected due date was 22-dec-2006. Product use was discontinued on an unk date in 2006. As of the following month, the outcome of the pregnancy was unk. Add'l info rec'd on 20-feb-2007 via a pregnancy questionnaire has upgraded this case to serious. A pregnant female consumer used one sheet of neosporin scar solution sheet (silicone) about every twelve hrs daily in 2005. Product use was discontinued in 2006. The consumer's expected due date was eight months later. Two months earlier, the consumer, gave birth to a nine-week premature infant male. The baby was four pounds and seventeen inches long. At one min, his apgar score was 8. 9. The infant spent six and one half weeks in the neonatal intensive care unit (nicu). As of 2007, the outcome of the event was unk.
Patient Sequence No: 1, Text Type: D, B5
[20706374]
The product was not returned for failure analysis/laboratory 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 | 2246407-2007-00001 |
| MDR Report Key | 823812 |
| Report Source | 04 |
| Date Received | 2007-02-28 |
| Date of Event | 2006-07-20 |
| Date Mfgr Received | 2007-02-20 |
| Date Added to Maude | 2007-03-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 201 TABOR RD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733850704 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOSPORIN SCAR SOLUTION |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2007-02-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 21666-3 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 811214 |
| Manufacturer | JOHNSON & JOHNSON GROUP OF CONSUMER COS. |
| Manufacturer Address | * MORRIS PLAINS NJ 07950 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-02-28 |