MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-30 for SUR-FIT NATURA SKIN BARRIER 413155 manufactured by Convatec.
[396352]
One month after skin condition began, patient seen by nurse for red, irritated, itchy skin with satellite lesions typical of yeast. At that time patient was switched to solid dh wafer and given diflucan and instructed to use nystatin powder. Nurse states patient was non-compliant. Nurse also tried switching customer to hollister but skin did not improve markedly. Nurse believes to be fungal by physician requests ingredients statement to check for allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00027 |
| MDR Report Key | 597426 |
| Report Source | 05 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 2003-09-30 |
| Date Mfgr Received | 2003-10-31 |
| Date Added to Maude | 2005-05-03 |
| 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 Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA SKIN BARRIER |
| Generic Name | OSTOMY APPLIANCE |
| Product Code | EZS |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 413155 |
| Lot Number | UNK |
| 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 | 587254 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT NATURA DURAHESIVE SKIN BARRIER |
| Baseline Generic Name | SKIN BARRIER WITH FLANGE |
| Baseline Model No | NA |
| Baseline Catalog No | 413155 |
| Baseline ID | NA |
| Baseline Device Family | OSTOMY APPLIANCE AND ACCESSORIES |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-30 |