MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-01-04 for CLIP SLING TGS.402 manufactured by Medibo Medical Products N.v..
[2568311]
It was described that during a pt transfer using a medibo sling the right side leg clip broke. The pt's leg dropped onto the bed positioned directly below and the rest of their body remained positioned in the sling. No injuries were sustained.
Patient Sequence No: 1, Text Type: D, B5
[9586200]
This report is being filed under exemption (b)(4) by arjohuntleigh on behalf of the mfr medibo medical products (b)(4). The eval of the device to date has been carried out by a rep of the mfr's sales and service unit subsidiary division, not a direct employee of the mfr. Add'l info will be provided following the conclusion of the mfr's investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004468271-2012-00002 |
| MDR Report Key | 2417725 |
| Report Source | 01,06 |
| Date Received | 2012-01-04 |
| Date of Report | 2011-12-09 |
| Date of Event | 2011-12-08 |
| Date Facility Aware | 2011-12-21 |
| Report Date | 2012-01-04 |
| Date Reported to FDA | 2012-01-04 |
| Date Reported to Mfgr | 2012-01-04 |
| Date Mfgr Received | 2011-12-09 |
| Date Added to Maude | 2012-07-27 |
| 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 | 0 |
| Manufacturer Contact | STEVE HELLSTROM |
| Manufacturer Street | 2349 WEST LAKE ST |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 8003231245 |
| Manufacturer G1 | MEDIBO MEDICAL PRODUCTS N.V. |
| Manufacturer Street | HEIKANT 5 |
| Manufacturer City | HANMONT-ACHEL 3930 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | 3930 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIP SLING |
| Generic Name | SLING |
| Product Code | ILI |
| Date Received | 2012-01-04 |
| Model Number | TGS.402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIBO MEDICAL PRODUCTS N.V. |
| Manufacturer Address | HAMONT-ACHEL BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-04 |