MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-27 for HYGIENIKIT 17152 manufactured by Ameda Inc..
[4719473]
On (b)(6) 2014, an ameda sales representative, working with (b)(4), sent an email to inform ameda that one week prior, an inpatient was cut while using dual hygienikit breast flanges while pumping with the multi-user platinum pump. Per the sales representative, the patient was not fitted for proper flange size until after the injury. At the time, the patient reported "rubbing while pumping". The hospital declined to release patient information due to hippa regulations.
Patient Sequence No: 1, Text Type: D, B5
[12356024]
The ameda sales representative met with the hospital nurse manager on (b)(6) 2014 and reviewed the importance of proper breast flange fit. The representative gave the hospital new platinum quick cards with breast flange fit guidelines.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009974348-2014-00015 |
| MDR Report Key | 4101581 |
| Report Source | 07 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-05 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-08-05 |
| Device Manufacturer Date | 2014-06-05 |
| 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 E HALF DAY RD STE 320 |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8479642620 |
| Single Use | 3 |
| Remedial Action | PM |
| 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 |
| Catalog Number | 17152 |
| Lot Number | 4E10 |
| Operator | HEALTH PROFESSIONAL |
| 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 |