MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-04-28 for REMOVE 8OZ WIPES 59403125 manufactured by Smith & Nephew, Inc..
[5707823]
It was reported that a patient developed a mild skin reaction, blistering, after usage of remove prior to placing a covidien ecg sensor on the patient? S skin. The reporter states that it is unknown the causal relationship with the remove product or the ecg sensor? S adhesive.
Patient Sequence No: 1, Text Type: D, B5
[13260551]
.
Patient Sequence No: 1, Text Type: N, H10
[29924077]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00043 |
| MDR Report Key | 4734889 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-04-28 |
| Date of Report | 2015-04-17 |
| Date of Event | 2015-04-17 |
| Date Mfgr Received | 2015-04-17 |
| Date Added to Maude | 2015-04-29 |
| 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 | 3 |
| Manufacturer Contact | MR. TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer Phone | 7273993785 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMOVE 8OZ WIPES |
| Generic Name | REMOVE WIPES CTN 50 |
| Product Code | KOX |
| Date Received | 2015-04-28 |
| Catalog Number | 59403125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-28 |