MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-06-29 for MSP SCHMEISER PROCEDURE KIT MSPKIT manufactured by Outside Vendor/unk.
[2044756]
According to the reporter: the needles break away from the star wires.
Patient Sequence No: 1, Text Type: D, B5
[9208814]
(b)(4). Date of initial report sent: (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219161-2011-00004 |
| MDR Report Key | 2184241 |
| Report Source | 01,06 |
| Date Received | 2011-06-29 |
| Date of Report | 2011-05-30 |
| Date of Event | 2011-05-26 |
| Date Mfgr Received | 2011-05-30 |
| Date Added to Maude | 2012-05-15 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 150 GLOVER AVE. |
| Manufacturer City | NORWALK CT 06856 |
| Manufacturer Country | US |
| Manufacturer Postal | 06856 |
| Manufacturer Phone | 2034926273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MSP SCHMEISER PROCEDURE KIT |
| Generic Name | NONE |
| Product Code | FHO |
| Date Received | 2011-06-29 |
| Catalog Number | MSPKIT |
| Lot Number | 1050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OUTSIDE VENDOR/UNK |
| Manufacturer Address | 150 GLOVER AVE. NORWALK CT 06858 US 06858 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-29 |