N
Patient 1
MAUDE MDR 5384739
- MDR report key
- 5384739
- Report number
- 3006760724-2016-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-12-17
- Date received
- 2016-01-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS CLAUDIA ODOY
- Address
- SCHACHENALLEE 29 AARAU 5001 SZ
- Phone
- 62-62-0628
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SKIN PREP WIPES | SKIN-PREP WIPES CTN 50 | SMITH & NEPHEW, INC. | KMF | 59420425 | 59420425 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-01-22 | 0 | 1. O |
Event Narratives#
D
Patient 1
AN ADVERSE SAKIN REACTION WAS REPORTED. FOLLOWING USE OF SKIN PREP-PROTECTIVE BARRIER WIPES AND UNIVERSAL ADHESIVE REMOVER WIPES, SKIN REACTION, SUSPECTED TO BE ECZEMA OCCURED. FOLLOWING EPICUTANEOUS TESTING THIS WAS DETERMINED TO BE CONTACT ALLERGIC DERMATITIS.
N
Patient 1