MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-10-26 for NUT manufactured by Synthes (usa).
[3086552]
Device report from (b)(4) reports an event in (b)(6) as follows: patient underwent a revision procedure on (b)(6) 2011. Resolving haematoma was identified and washed out copiously. Tissues samples were taken and sent for microscopy culture and sensitivity. The wound was closed. This is # 38 of 50 reports for the same event.
Patient Sequence No: 1, Text Type: D, B5
[10281511]
Device was used for treatment. Investigation could not be completed, no conclusion could be drawn as device was not returned and lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02691 |
| MDR Report Key | 2805769 |
| Report Source | 01,07 |
| Date Received | 2012-10-26 |
| Date of Report | 2012-08-29 |
| Date Mfgr Received | 2012-08-29 |
| Date Added to Maude | 2012-10-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARISSE BALL |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NUT |
| Product Code | LYT |
| Date Received | 2012-10-26 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-26 |