MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-12 for STRYKER GLIDE SYSTEM 3061000000 manufactured by Stryker Medical-kalamazoo.
[3887540]
It was reported that there was an injury due to use of the air glide system. No additional information on the injury or possible malfunction have been provided at this time. Manufacturer's investigation is ongoing. If additional information is received, a follow-up report may be submitted. There was patient involvement; however, no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[15181217]
It was reported that there was an injury due to use of the air glide system. No additional information on the injury or possible malfunction have bee provided at this time. Manufacturer's investigation is ongoing. If additional information is received, a follow-up report may be submitted. There was patient involvement; however, no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[15635139]
Upon completion of the manufacturer's investigation it was found that the customer had alleged that the glide mattress may had malfunctioned, but the investigator could not confirm the event. The customer also reported that the glide mattress was disposed of before an evaluation could be done. The customer reported a few different events because the customer's staff gave different reports; however, the event may have been due to user error. The customer's staff was communicated to on the proper use of the device. Additionally, no adverse event was confirmed by the customer and no additional information was provided. However, it was confirmed that there was no patient involvement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001831750-2013-07201 |
| MDR Report Key | 3281664 |
| Report Source | 06 |
| Date Received | 2013-08-12 |
| Date of Report | 2013-07-16 |
| Date of Event | 2013-07-16 |
| Date Mfgr Received | 2013-07-16 |
| Date Added to Maude | 2013-11-06 |
| 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 | MR. ANTHONY NOORA |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER GLIDE SYSTEM |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2013-08-12 |
| Catalog Number | 3061000000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-12 |