MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-31 for DRIVE MEDICAL RTL728RD NA manufactured by Shanghai Shunlong Physical Therapy Equipment Co..
[16675734]
Drive medical has received a complaint from claimant? S daughter about an incident involving a rollator, allegedly distributed by drive medical. It is reported that the end user had been using the rollator for one year. On the day of incident, the claimant was in the lobby of his building when he locked the brakes and went to sit down. The brakes allegedly distributed by drive medical. It is reported that the end user had been using the rollator for one year. On the day of incident, the claimant was in the lobby of his building when he locked the brakes and went to sit down. The brakes allegedly did not lock correctly and the rollator slipped away causing him to fall and allegedly sustained head injury resulting in receiving six (6) stitches. Drive has been reaching out to the claimant? S daughter and tried to have the alleged product returned for further inspection. As of this date, they have refused to do so. This mdr is based on the claimant? S daughter complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2012-00010 |
| MDR Report Key | 2603258 |
| Date Received | 2012-05-31 |
| Date of Report | 2012-05-01 |
| Date of Event | 2012-04-21 |
| Date Facility Aware | 2012-05-01 |
| Report Date | 2012-05-31 |
| Date Reported to Mfgr | 2012-05-31 |
| Date Added to Maude | 2012-06-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Manufacturer Street | 99 SEAVIEW BLVD. |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer G1 | MEDICAL DEPOT |
| Manufacturer Street | 99 SEAVIEW BLVD. |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11050 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | ROLLATOR |
| Product Code | NXE |
| Date Received | 2012-05-31 |
| Model Number | RTL728RD |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| 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. Required No Informationntervention | 2012-05-31 |