MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-04-27 for STRETCHAIR PT TRANSFER SYSTEMS, INC. MC675CLTP UMK manufactured by Stretchair Patient Transfer Systems, Inc..
[18831621]
Pt moved himself up in chair with assist from nursing staff. Later he stated he leaned forward and the buckle on the seatbelt came loose and he fell forward out of chair.
Patient Sequence No: 1, Text Type: D, B5
[18907889]
Eval of the seat belt indicated under normal conditions that functioned as required. When the seat belt received a significant dynamic pull on each side of the latch, the latch did release. The internal spring within the latching mechanism was not properly engaging the locking clip. All current inventories of seat belts have been checked and no defective units have been found. This is an isolated case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043565-2005-00001 |
| MDR Report Key | 964107 |
| Report Source | 06 |
| Date Received | 2006-04-27 |
| Date of Report | 2006-03-28 |
| Date of Event | 2006-03-01 |
| Date Facility Aware | 2006-03-17 |
| Report Date | 2006-03-31 |
| Date Reported to FDA | 2006-03-31 |
| Date Reported to Mfgr | 2006-03-31 |
| Date Mfgr Received | 2006-04-04 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2007-12-17 |
| 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 Street | 8110 ULMERTON RD |
| Manufacturer City | LARGO FL 33771 |
| Manufacturer Country | US |
| Manufacturer Postal | 33771 |
| Manufacturer Phone | 7275312444 |
| Manufacturer G1 | STRETCHAIR PTS, INC. |
| Manufacturer Street | 8110 ULMERTON RD |
| Manufacturer City | LARGO FL 33771 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33771 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRETCHAIR PT TRANSFER SYSTEMS, INC. |
| Generic Name | STRETCHAIR |
| Product Code | IQC |
| Date Received | 2006-04-27 |
| Model Number | MC675CLTP |
| Catalog Number | UMK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 684526 |
| Manufacturer | STRETCHAIR PATIENT TRANSFER SYSTEMS, INC. |
| Manufacturer Address | 8110 ULMERTON RD. LARGO FL 33771 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-27 |