MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-07 for NON081541 manufactured by Medline Industries Inc..
[173934153]
It was reported that the facility was performing a procedure on a patient and while the patient was strapped with the body strap and leaned to the side the staff reported that the hook and loop became disengaged and the patient fell to the ground resulting in a fracture to an unspecified location of the patient's skull. Due diligence has been completed. No additional details are available related to the customer reported issue. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer. The sample has not been returned for evaluation. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[173934334]
The facility reported that the loop and hook from the positioning strap failed during a procedure causing a patient to fall off the table and fracture her skull.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00229 |
| MDR Report Key | 9557519 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-07 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | STRAPS: DISPOSABLE FOAM KNEE / BODY STRAP, 4" X 60" |
| Product Code | CCX |
| Date Received | 2020-01-07 |
| Catalog Number | NON081541 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-07 |