MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-18 for MIDMARK 647-002 manufactured by Midmark Corp..
[1947189]
Customer had a patient complain they could feel the staples when using the armrest.
Patient Sequence No: 1, Text Type: D, B5
[9102313]
The staples holding the vinyl to the arm board were too long and not to specifications. This allowed part of the staple to exit the side of the arm board into the foam padding. Over time, the vinyl wore to the point that the end of the staple was able to contact the patient. The arms were replaced on three separate chairs. Only 1 of the six arms was defective. We were unable to determine which serial number of chair the defective arm was from. The serial numbers of the three chairs are: (b)(4), manufacture date: 03/2009, (b)(4), manufacture date: 08/2010, (b)(4), manufacture date: 08/2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00010 |
| MDR Report Key | 2070382 |
| Report Source | 06 |
| Date Received | 2011-04-18 |
| Date of Report | 2011-04-15 |
| Date of Event | 2011-03-22 |
| Date Mfgr Received | 2011-03-22 |
| Date Added to Maude | 2011-05-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2011-04-18 |
| Returned To Mfg | 2011-04-11 |
| Model Number | 647-002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-18 |