MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-22 for LATERAL ARM SUPPORT 6320 manufactured by Posey Products Llc.
[100704714]
Product is scheduled to be returned but have not been received in by manufacturing at the time of this report. Therefore, this report is based solely on the information provided by the customer. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instruction for use were reviewed and determined to provide adequate instructions and warning for safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are intended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100704715]
Customer reported while the lateral armrest was in use with a patient the patient suffered a skin tear from the "posey tag" that is sewn on the armrest. Customer provided additional information stating the skin tear was treated by band-aid from a nurse. Customer stated the label that scratched the patient was a raised hard rubber material. The date the incident occurred was not reported.
Patient Sequence No: 1, Text Type: D, B5
[115008885]
After multiple attempts, the product was not received in. Without the device, the reported issue could not be confirmed and possible causes for patient injury could not be determined. Historical data review showed no other complaint against this or similar products where the customer suffered skin tears from the tags. The instruction for use was reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. The ifu stated "inspect before each use: check for broken stitches; or torn, cut or frayed material. Do not use soiled or damaged products. " at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure code will be assessed, documented and acted upon as warranted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115008886]
Supplemental required for additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00016 |
| MDR Report Key | 7289534 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-22 |
| Date of Report | 2018-03-28 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2018-02-22 |
| 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 | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATERAL ARM SUPPORT |
| Generic Name | ACCESSORIES, WHEELCHAIR |
| Product Code | KNO |
| Date Received | 2018-02-22 |
| Model Number | 6320 |
| Catalog Number | 6320 |
| Lot Number | UNK |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-22 |