MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for MODEL 4200 PNEUMATIC SERIES STOOLS manufactured by Reliance Medical Products, Inc..
[89429980]
No injury has been reported with this concern at this time. Further follow-up will be performed as necessary.
Patient Sequence No: 1, Text Type: N, H10
[89429981]
(b)(6) from (b)(6) reported that the stool seat broke. (b)(4) from reliance medical products asked the customer how this happened and he stated, "i just sat down, leaned back and the seat snapped. " he has several (b)(4) stools that they have purchased from reliance medical products over the years. The strange thing is that the person involved with this event is not a very large male, approximately (b)(6) pounds. The individual involved was not hurt due to this concern.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523545-2017-00002 |
| MDR Report Key | 6892358 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-18 |
| Date Facility Aware | 2017-08-18 |
| Device Manufacturer Date | 2014-06-26 |
| Date Added to Maude | 2017-09-25 |
| 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. MARK BEISMANN |
| Manufacturer Street | 3535 KINGS MILLS DRIVE |
| Manufacturer City | MASON OH 450402303 |
| Manufacturer Country | US |
| Manufacturer Postal | 450402303 |
| Manufacturer Phone | 5133983937 |
| Manufacturer G1 | RELIANCE MEDICAL PRODCUTS, INC. |
| Manufacturer Street | 3535 KINGS MILLS ROAD |
| Manufacturer City | MASON OH 450402303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 450402303 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MODEL 4200 PNEUMATIC SERIES STOOLS |
| Generic Name | MODEL 4246 PNEUMATIC STOOL |
| Product Code | HMD |
| Date Received | 2017-09-25 |
| Model Number | 4200 |
| Lot Number | SEE SERIAL NUMBER |
| Device Expiration Date | 2015-06-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 3535 KINGS MILLS ROAD MASON OH 450402303 US 450402303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |