MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for UNKNOWN BONE CEMENT UNK CEMENT manufactured by Depuy Cmw - 9610921.
[188328673]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188328674]
A patient has reported that he is experiencing lung and eye problems due to cement. He also indicates he has terminal cancer due to cement. No further information is provided at this time. Doi: unknown. Dor: none reported; unknown side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09080 |
| MDR Report Key | 9873434 |
| Report Source | CONSUMER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-03-24 |
| 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 | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY CMW - 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN BONE CEMENT |
| Generic Name | BONE CEMENT |
| Product Code | LOD |
| Date Received | 2020-03-24 |
| Catalog Number | UNK CEMENT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY CMW - 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |