MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1999-02-09 for ARJO STANDARD SLING MAA4000-L NA manufactured by Arjo Ltd.
[144288]
Pt was being transferred from bed to chair. Pt started to cough causing pt body to "jackknife". The pt's leg braces appeared to catch both clips forcing them off sling attachment clips on lift. Pt immediately fell out of sling to the ground. Laceration over right eye, required 8-10 stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617021-1999-00002 |
| MDR Report Key | 209042 |
| Report Source | 06,07 |
| Date Received | 1999-02-09 |
| Date of Report | 1999-02-08 |
| Date of Event | 1999-02-03 |
| Date Added to Maude | 1999-02-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARJO STANDARD SLING |
| Generic Name | PT SUPPORT SLING |
| Product Code | ILI |
| Date Received | 1999-02-09 |
| Model Number | MAA4000-L |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 202875 |
| Manufacturer | ARJO LTD |
| Manufacturer Address | ST. CATHERINE ST GLOUCESTER UK GL1 2SL |
| Baseline Brand Name | STANDARD SLING |
| Baseline Generic Name | * |
| Baseline Model No | MAA4000-L |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-02-09 |