MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-21 for 80 X 36 X 6 INNERSPRING MATTRESS 1633 9153647268 NA:5185 5185 manufactured by Capital Bedding.
[145676671]
The mattress was not returned to invacare, but a picture was received. Based on the picture provided by the reporter, the alleged issue of there being an unfinished curled spring coming out of the mattress could not be confirmed. The caller has not responded to repeated attempts to get more information concerning the injury, treatment, and the incident in general. Invacare is filing this report in an abundance of caution. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145676672]
Invacare received the following complaint: the caregiver alleges while attempting to make the bed using a fitted sheet, her hand caught on an unfinished curled spring on the 5185 mattress. She sustained a 1? Laceration to her left palm which required sutures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2019-00004 |
| MDR Report Key | 8628833 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-21 |
| Date of Report | 2019-04-22 |
| Report Date | 2019-05-21 |
| Date Reported to Mfgr | 2019-05-21 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-05-21 |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 80 X 36 X 6 INNERSPRING MATTRESS 1633 9153647268 |
| Generic Name | COVER, MATTRESS (MEDICAL PURPOSES) |
| Product Code | FMW |
| Date Received | 2019-05-21 |
| Model Number | NA:5185 |
| Catalog Number | 5185 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAPITAL BEDDING |
| Manufacturer Address | 5262 RAYMOND AVE VERONA MS 38879 US 38879 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-21 |