MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-28 for UNKNOWN manufactured by Halyard Health.
[58663450]
(b)(4). The actual complaint product was not returned for evaluation. Root cause could not be determined. A review of the device history record is not possible as the specific device is unknown and no lot number was provided. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[58663451]
It was reported that there was a fall in the c-section room, due to an alleged lack of traction on the unknown shoe cover the user was wearing. The user was trying to move a patient to the operating room, and broke her elbow in the fall. Per additional information received on 12 oct 2016, the fall occurred around the end of (b)(6) or beginning of (b)(6). It is unknown how long the user was wearing the booties. The floor type in the room was laminate, and per the reporter, "amniotic fluid was everywhere. " the user was out of work for 8-10 weeks as a result of the injury. Treatment included the elbow being immobilized, and physical therapy, but no surgery was required. No further information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2016-00016 |
| MDR Report Key | 6064333 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-10 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-10-28 |
| 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 | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | HALYARD HEALTH, INC. |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN SHOE COVER |
| Product Code | FXP |
| Date Received | 2016-10-28 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-28 |