MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-01-17 for REMOVE WIPES 403100 manufactured by Smith & Nephew.
[444872]
Pt was connected to a heart monitor by the respiratory therapist using five leads. The leads were connected after the area was wiped with remove (instead of skin prep). Pt wore the monitor for 24 hours, and when the leads were removed the respiratory therapist noticed the areas were red and blistered, similar to a burn. The facility noted that this was human error due to similar appearance of packaging for skin prep and remove wipes. The pt was referred to wound care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017593-2006-00003 |
| MDR Report Key | 664880 |
| Report Source | 06 |
| Date Received | 2006-01-17 |
| Date of Report | 2005-12-16 |
| Date of Event | 2005-12-16 |
| Date Mfgr Received | 2005-12-16 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2006-01-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIM IRVIN |
| Manufacturer Street | 11775 STARKEY ROAD |
| Manufacturer City | LARGO FL 337791970 |
| Manufacturer Country | US |
| Manufacturer Postal | 337791970 |
| Manufacturer Phone | 7273921261 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMOVE WIPES |
| Generic Name | ADHESIVE TAPE SOLVENT |
| Product Code | KOX |
| Date Received | 2006-01-17 |
| Model Number | 403100 |
| Catalog Number | 403100 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 654286 |
| Manufacturer | SMITH & NEPHEW |
| Manufacturer Address | 11775 STARKEY RD. LARGO FL 337791970 US |
| Baseline Brand Name | REMOVE |
| Baseline Generic Name | ADHESIVE TAPE REMOVER |
| Baseline Catalog No | 403100 |
| Baseline Device Family | ADHESIVE TAPE REMOVER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-17 |