MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-05-23 for NEOSPORIN SCAR SOLUTION 22040-28 manufactured by Pfizer Inc.
[18339787]
A female consumer used 1 sheet of neosporin scar solution silicone scar sheet (silicone) once in 2007. For a scar on her left arm. At 7:30 pm the same day, she had rapid heart beat of 160 (unit unspecified) and a metallic taste in her mouth. She went to the emergency room and received an unspecified intravenous with an unspecified medication to slow her heart rate. Her "heart enzymes were ok" and blood work came out fine. After six hours observation, "they found nothing wrong" she was released. At the time of reporting on two days later, the events resolved.
Patient Sequence No: 1, Text Type: D, B5
[18382172]
The prod was not returned for failure analysis/lab testing. It cannot be ruled out that the prod may have possibly caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2007-00003 |
| MDR Report Key | 855339 |
| Report Source | 04 |
| Date Received | 2007-05-23 |
| Date of Report | 2007-05-16 |
| Date of Event | 2007-05-14 |
| Date Mfgr Received | 2007-05-16 |
| Date Added to Maude | 2007-09-04 |
| 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 | 201 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733850704 |
| Single Use | 0 |
| 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 | 2007-05-23 |
| Model Number | 22040-28 |
| Device Expiration Date | 2007-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 843890 |
| Manufacturer | PFIZER INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-23 |