MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-23 for PROCAIR PLUS MATTRESS 222-3680 manufactured by Joerns Healthcare.
[176961032]
This report or other information submitted by joerns healthcare under 21 cfr part 803, and any release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176961033]
It was reported to the manufacturer by the end user, per the end user, patient is now hospitalized due to pressure injuries he received from our mattress. The caregiver was contacted to receive additional information and details related to this alleged incident report with no response from the caregiver. Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the mattress, control unit and bed returned to joerns for investigation. As of this writing, the mattress, control unit and bed have not been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2020-00010 |
| MDR Report Key | 9623255 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-23 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | JOERNS HEALTHCARE |
| Manufacturer Street | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL |
| Manufacturer City | MATAMOROS, 87499 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 87499 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCAIR PLUS MATTRESS |
| Generic Name | PATIENT AIR MATTRESS |
| Product Code | FNM |
| Date Received | 2020-01-23 |
| Model Number | 222-3680 |
| Catalog Number | 222-3680 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOERNS HEALTHCARE |
| Manufacturer Address | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL MATAMOROS, 87499 MX 87499 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-23 |