MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-01-15 for TRIPLE CARE EPC/EPB GB59432500 manufactured by Smith & Nephew, Inc..
[36025369]
.
Patient Sequence No: 1, Text Type: N, H10
[36025370]
Adverse skin reaction a report of erythema and skin slushing off and peeling within three days of application. Treatment was stopped immediately and cream applied. The skin is no longer red and peeling.
Patient Sequence No: 1, Text Type: D, B5
[46257364]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2016-00001 |
| MDR Report Key | 5369230 |
| Report Source | CONSUMER |
| Date Received | 2016-01-15 |
| Date of Report | 2015-12-30 |
| Date of Event | 2015-12-23 |
| Date Mfgr Received | 2015-12-30 |
| Date Added to Maude | 2016-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CLAUDIA ODOY |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU5 3BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU5 3BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIPLE CARE EPC/EPB |
| Generic Name | SECURA EXTRA PROT CRM 7.75OZ |
| Product Code | NEC |
| Date Received | 2016-01-15 |
| Model Number | GB59432500 |
| Catalog Number | GB59432500 |
| Device Expiration Date | 2018-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-01-15 |