MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-21 for WALKER G30755P manufactured by Medline Industries, Inc..
[4314595]
The front leg of the walker broke, the end user fell and was diagnosed with a ganglion cyst of his left wrist.
Patient Sequence No: 1, Text Type: D, B5
[11630794]
The end user reported that the front left leg of the walker broke and he fell, suffering a ganglion cyst of his left wrist. He states the walker was one year old. He did not return the sample for eval and no lot number was provided to us. Photos provided by the end user showed a full fracture on one left of the product, and a partial fracture on another leg of the product. It could not be confirmed by the evidence provided whether the front or rear legs of the sample had fractured. The partial fracture was indicative of the walker leg being bent inwards. Further info or a physical sample is necessary to determine the root cause of the incident. There were no photos of the entire device and we have not been able to confirm the identity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00015 |
| MDR Report Key | 3649406 |
| Report Source | 04 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-01-11 |
| Date Mfgr Received | 2014-01-16 |
| Date Added to Maude | 2014-02-28 |
| 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 | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKER |
| Product Code | INP |
| Date Received | 2014-02-21 |
| Catalog Number | G30755P |
| Lot Number | UNK |
| 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 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-21 |