MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-23 for PROFLEX RESTRAINT STRAP UNK manufactured by Professional Specialties Co., Inc..
[113161]
Pt admitted for hysterectomy. After pt had been extubated, as was waking up, strap holding legs in place on or table came loose; pt fell to floor. Top clip on metal hook on strap was not present. Pt was apparently moving around when strap came off. Anesthetist was standing by table and partially broke fall. 36 hours post incident, pt. Dx. With lacerated spleen; transferred to iccu for monitoring. Pt discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 128266 |
| MDR Report Key | 128266 |
| Date Received | 1997-10-23 |
| Date of Report | 1997-09-23 |
| Date of Event | 1997-09-10 |
| Date Facility Aware | 1997-09-10 |
| Report Date | 1997-09-23 |
| Date Reported to Mfgr | 1997-09-23 |
| Date Added to Maude | 1997-10-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFLEX RESTRAINT STRAP |
| Generic Name | RESTRAINT STRAP FOR OR TABLE |
| Product Code | BRT |
| Date Received | 1997-10-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 125500 |
| Manufacturer | PROFESSIONAL SPECIALTIES CO., INC. |
| Manufacturer Address | PO BOX 16043 ST. LOUIS MO 63105 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 1997-10-23 |