MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-10-07 for HYGEIA FLANGE manufactured by Hygeia Ii Medical Group Inc..
[28366512]
The customer service representative troubleshooted with the customer at the date of the event and found that the pump sounded fine, and the piece of plastic on the flange assembly located inside the flange assembly just above the part where the tubing is attached had a piece of plastic sticking out. The customer service representative sent complimentary flanges to the customer. The customer was also referred to go see a location consultant to have the flange size checked. On (b)(6) 2015, the customer service representative contacted the customer to follow-up with the flanges that the customer service representative had sent the customer. The customer was happy about the flanges that the customer service representative had sent the customer, and the customer stated that the customer did not have any issues or concerns.
Patient Sequence No: 1, Text Type: N, H10
[28366513]
Customer contacted our customer service representative on (b)(6) 2015 stating that there was a nick in the plastic on the inside of one of the flanges. The flange got caught on the customers skin, causing the customer to bleed. The customer stated that the customer felt a rough spot on the flange a couple days prior to the date of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006774448-2015-00002 |
| MDR Report Key | 5150187 |
| Report Source | OTHER |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-09-11 |
| Date Mfgr Received | 2015-09-11 |
| Date Added to Maude | 2015-10-14 |
| 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 | JOHN GHERMAN |
| Manufacturer Street | 6005 HIDDEN VALLEY RD SUITE 230 |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7145157571 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYGEIA FLANGE |
| Generic Name | FLANGE |
| Product Code | HGY |
| Date Received | 2015-10-07 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGEIA II MEDICAL GROUP INC. |
| Manufacturer Address | 6005 HIDDEN VALLEY RD SUITE 230 CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-07 |