MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-12 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.
[79885292]
It was reported that the footrest of the recliner opened too forcefully, hitting a nurse in the shin and causing her to fall over. It was further reported that details of her injuries and any possible medical intervention related to this incident were unknown. No patient involvement and no adverse consequence or clinically relevant delay in treatment for a patient was reported, and no further information regarding the alleged incident were given at this time.
Patient Sequence No: 1, Text Type: D, B5
[91128321]
It was alleged that a nurse had been down on her hands and knees when she pulled the recliner lever and the footrest hit her in the chin. It was not reported if the nurse recieved medical treatment following the event. This issue was resolved for the customer by following up with the customer to ensure that no further assistance was needed. Unit was not identified for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[91128322]
It was reported that the footrest of the recliner opened too forcefully, hitting a nurse in the shin and causing her to fall over. It was further reported that details of her injuries and any possible medical intervention related to this incident were unknown. No patient involvement and no adverse consequence or clinically relevant delay in treatment for a patient was reported, and no further information regarding the alleged incident were given at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00294 |
| MDR Report Key | 6708615 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-12 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-13 |
| Date Added to Maude | 2017-07-12 |
| 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 Contact | MR. CHANDA BURGHARD |
| 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 | UNKNOWN_MEDICAL_PRODUCT |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2017-07-12 |
| Catalog Number | UNK_MED |
| 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 | 2017-07-12 |