MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-27 for HYGIENIKIT manufactured by Ameda Inc..
[4762947]
The customer contacted ameda on (b)(6) 2014 via phone call. She stated that she developed a red rash when using the hygienikit flanges.
Patient Sequence No: 1, Text Type: D, B5
[12173125]
The customer has been under the care of a lactation consultant and has been using a cortisone cream and lanolin preparation to manage her symptoms. The customer has declined an offer to speak with ameda's lactation consultant. Three voice mail messages were left with the customer to further assess her rash and one voice message left further assess her rash and one voice message left asking customer to provide the flange lot number, located on package insert. To date, the customer has not returned the calls. No product return is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009974348-2014-00027 |
| MDR Report Key | 4101601 |
| Report Source | 04 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-07-31 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-07-31 |
| Date Added to Maude | 2014-09-22 |
| 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 Street | 485 HALF DAY RD. SUITE 320 |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8479642620 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYGIENIKIT |
| Generic Name | PUMP, BREAST NON-POWERED |
| Product Code | HGY |
| Date Received | 2014-08-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDA INC. |
| Manufacturer Address | BUFFALO GROVE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-27 |