MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-07-10 for ULTEC DRESSING * 8884475400 manufactured by Tyco/healthcare/kendall.
[249831]
It was reported to tyco/healthcare/kendall in 2002 that a skin tear occurred when the dressing was removed. The staff reported that they were doing routine skin assessment and when they removed that dressing it tore the skin causing a wound. The dressing was being used for preventive measures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314412-2002-00008 |
| MDR Report Key | 405412 |
| Report Source | 07 |
| Date Received | 2002-07-10 |
| Date of Report | 2002-07-09 |
| Date of Event | 2002-06-01 |
| Date Mfgr Received | 2002-06-20 |
| Date Added to Maude | 2002-07-19 |
| 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 | 0 |
| Manufacturer Contact | PAUL LAVALLEE |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618547 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTEC DRESSING |
| Generic Name | HYDROCOLOID DRESSING |
| Product Code | MGQ |
| Date Received | 2002-07-10 |
| Model Number | * |
| Catalog Number | 8884475400 |
| Lot Number | 201650 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 394411 |
| Manufacturer | TYCO/HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Baseline Brand Name | ULTEC HYDROCOLLOID DRESSING |
| Baseline Generic Name | HYDROCOLLOID DRESSING |
| Baseline Model No | NA |
| Baseline Catalog No | 8884475400 |
| Baseline ID | NA |
| Baseline Device Family | HYDROCOLLOID DRESSING |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K862803 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-10 |