MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-18 for 4575 FMS DUO+ PUMP/SHAVER COMBO -NS 284575 manufactured by Depuy Mitek Llc Us.
[185077540]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi:(b)(4). The serial number is unknown
Patient Sequence No: 1, Text Type: N, H10
[185077541]
It was reported by affiliate via mail that before procedure the 4575 fms duo+ pump/shaver combo -ns has a broken cover. No patient consequences or surgical delay reported. The device is available to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00895 |
| MDR Report Key | 9848725 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY MITEK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4575 FMS DUO+ PUMP/SHAVER COMBO -NS |
| Generic Name | DISTENSION UNIT, FLUID, ARTHROSCOPIC |
| Product Code | HRX |
| Date Received | 2020-03-18 |
| Catalog Number | 284575 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |