MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-19 for COLLODION REMOVER, GALLON * M040 manufactured by Integra Lifesciences Corporation.
[464154]
A pediatric patient developed an allergic reaction after the collodian remover was used. The patient was treated for the swelling and rash with a cream. The patient was discharged. The lot is unknown. The sleep center has previously used the collodian remover on both adult and pediatric patients with no adverse reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2006-00011 |
| MDR Report Key | 701284 |
| Date Received | 2006-04-19 |
| Date of Report | 2006-04-19 |
| Date Facility Aware | 2006-03-13 |
| Report Date | 2006-04-12 |
| Date Added to Maude | 2006-04-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLODION REMOVER, GALLON |
| Generic Name | ELECTRODE APPLICATION |
| Product Code | KOX |
| Date Received | 2006-04-19 |
| Model Number | * |
| Catalog Number | M040 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 690392 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | * PLAINSBORO NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-19 |