MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-16 for BOOT COVER NON27143 manufactured by Medline Industries, Inc..
[19351951]
It was reported that the end user slipped while wearing the boot covers and fractured his wrist.
Patient Sequence No: 1, Text Type: D, B5
[19707218]
It was reported that a physician assistant slipped in the operating room. In an attempt to break his fall he grabbed onto something which resulted in a fractured wrist. The actual sample was not returned. We received unused samples from an undetermined lot. No defects were identified with the returned samples. A root cause has not been determined. Minimal details were provided regarding the incident. It is unk if the end user was wearing the correct sized boot cover. It is also not known if the condition of the operating room floor was a cause or contributing factor to this incident. Due to the reported injury, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00029 |
| MDR Report Key | 4713488 |
| Report Source | 06 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2015-03-12 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-04-22 |
| 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 | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOOT COVER |
| Product Code | FXP |
| Date Received | 2015-04-16 |
| Catalog Number | NON27143 |
| Lot Number | 54214100769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-16 |