MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-06-07 for DRIVE MEDICAL 726BL UNK manufactured by Shanghai Shunlong Physical Therapy Equipment Co..
[2766025]
One of our distributors in the united states, (b)(6), has received an attorney letter alleging that the claimant was injured from one of rollators manufactured by shanghai shunlong. It was alleged that the rollator front-left bar cracked causing the claimant to fall and sustain sprain/strain in his neck, back and elbow. Pt's medical record showed no fracture. This mdr report is based on the mdr report submitted by (b)(4) and add'l info provided by this distributor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003910843-2012-00002 |
| MDR Report Key | 2619777 |
| Report Source | 08 |
| Date Received | 2012-06-07 |
| Date of Report | 2011-01-26 |
| Date of Event | 2009-07-12 |
| Date Mfgr Received | 2011-01-26 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2012-06-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RITA LIU |
| Manufacturer Street | NO. 259 JIUGAN RD SONGJIANG DISTRICT |
| Manufacturer City | SHANGHAI, SIJING TOWN 201601 |
| Manufacturer Country | CH |
| Manufacturer Postal | 201601 |
| Manufacturer Phone | 157626070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | ROLLATOR |
| Product Code | NXE |
| Date Received | 2012-06-07 |
| Model Number | 726BL |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO. |
| Manufacturer Address | SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-06-07 |