MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-21 for SECURA MOIST CLEANSER ED59430900 manufactured by Smith & Nephew, Inc..
[6052784]
It was reported that patient ingested 50ml of the product. The patient was asymptomatic at the time of the report.
Patient Sequence No: 1, Text Type: D, B5
[14381460]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00071 |
| MDR Report Key | 4928494 |
| Report Source | 05 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-07-21 |
| 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 | 0 |
| Event Location | 0 |
| 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 | SECURA MOIST CLEANSER |
| Generic Name | DEGREASER, SKIN, SURGICAL |
| Product Code | KOY |
| Date Received | 2015-07-21 |
| Catalog Number | ED59430900 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-07-21 |