MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-05-03 for 46-001 ST COVADERM 4X4 25 manufactured by Deroyal.
[225980]
Distributor received report from user facility regarding covaderm. Contact at user facility reported that at least four residents had experienced extremely red skin with blister-like areas where adhesive portion of bandage contacted patient's skin. User facility reported that in at least 2 of the 4 incidents, the patients developed blisters under the adhesive portion of the bandage. At this time, the user facility has not provided any additional info regarding the incidents. These incidents will be reported under medwatch reports 1123071-2001-00004 through 1123071-2001-00007.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1123071-2001-00004 |
| MDR Report Key | 330560 |
| Report Source | 08 |
| Date Received | 2001-05-03 |
| Date of Event | 2001-04-04 |
| Date Facility Aware | 2001-04-04 |
| Date Reported to FDA | 2001-05-04 |
| Date Mfgr Received | 2001-04-04 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2001-05-09 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 46-001 ST COVADERM 4X4 25 |
| Generic Name | COVADERM |
| Product Code | MSA |
| Date Received | 2001-05-03 |
| Returned To Mfg | 2001-04-18 |
| Model Number | NA |
| Catalog Number | 46-001 |
| Lot Number | 60156 |
| ID Number | NA |
| Device Expiration Date | 2005-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 319924 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | ADHESIVE DRESSING |
| Baseline Model No | NA |
| Baseline Catalog No | 46-001 |
| Baseline ID | NA |
| Baseline Device Family | WOUND DRESSING |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910657 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-03 |