MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2011-04-11 for SINCLAIR SKIN AND WOUND EMULSION 4102** manufactured by Sinclair Pharma Srl.
[2148492]
The pt was prescribed an antibiotic (tetralysal) and atopiclair, a non-steroid cream to alleviate the symptoms of atopic dermatitis, to be applied to the face. Following the treatment, the pt experienced edema on the face and visited a local hosp, where was admitted for five days.
Patient Sequence No: 1, Text Type: D, B5
[9119324]
Atopiclair is a non steroidal cream indicated to treat the symptoms of atopic dermatitis. As indicated in the product labeling, atopiclair contains shea butter (b)(4). The labeling warns pts with known allergy to this and/or known history of hypersensitivity to any of the ingredients to consult the physician before using the product. Based on the info rec'd on this case, an allergic reaction to the antibiotic seems more likely. In fact, atopiclair does not contain active ingredients. However, we cannot rule out that the product caused or contributed to cause the reported episode of hypersensitivity experienced by the pt (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003566785-2011-00002 |
| MDR Report Key | 2097741 |
| Report Source | 01,05,08 |
| Date Received | 2011-04-11 |
| Date of Report | 2010-01-22 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-01-22 |
| Date Added to Maude | 2011-05-26 |
| 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 | DANILO VERGANI, CORP. MGR |
| Manufacturer Street | VIALE RESTELLI, 29 |
| Manufacturer City | MILAN I-20124 |
| Manufacturer Country | IT |
| Manufacturer Postal | I-20124 |
| Manufacturer Phone | 230460301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINCLAIR SKIN AND WOUND EMULSION |
| Generic Name | ATOPICLAIR |
| Product Code | MGQ |
| Date Received | 2011-04-11 |
| Catalog Number | 4102** |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINCLAIR PHARMA SRL |
| Manufacturer Address | VIALE RESTELLI, 29 MILAN I-20124 IT I-20124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-04-11 |