MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2015-12-11 for AV SKIN CONDITIONER 324802 manufactured by Sysco Guest Supply Llc.
[33274142]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Blank fields on this form indicate the information is unknown, unavailable or unchanged. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[33274143]
Complainant reports "applied (b)(6) skin conditioner to legs and back. Nurses noted on that day the left leg had what she stated was a red raised prickly heat rash developing and moved to the groin area. Patient applied to back and buttock and noted last night was a flat macular rash and also noted this same flat rash to face and ears. Product use was discontinued. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249180-2015-40109 |
| MDR Report Key | 5289106 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-06 |
| Date of Event | 2011-12-03 |
| Date Mfgr Received | 2015-11-06 |
| Device Manufacturer Date | 2011-05-26 |
| Date Added to Maude | 2015-12-11 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AV SKIN CONDITIONER |
| Generic Name | SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2015-12-11 |
| Model Number | 324802 |
| Lot Number | G1E120 |
| Device Expiration Date | 2013-05-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSCO GUEST SUPPLY LLC |
| Manufacturer Address | 309 KENNEDY DR SAYREVILLE NJ 08872 US 08872 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-11 |