MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-07-07 for FILSHIE CLIP AVM-851 manufactured by Coopersurgical, Inc..
[17922195]
Filshie clip has not been returned to coopersurgical inc. For eval. Coopersurgical became aware of this event on (b)(6) 2011 via maude event report (b)(4). No reported events of similar on record. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[18044352]
Pt states she had filshie clips implanted on (b)(6) 2007 after the birth of her child. Immediately following the procedure, she experienced crushing fatigue, muscle and joint aches and abdominal pain. She continued to live with the pain until a blood clot formed in (b)(6) 2009 at the location of the clip which traveled to her lung, causing a pulmonary embolism. She had been on and off warfarin and has constant pain in both ovaries. She did some research and on (b)(6) 2011 she had the filshie clips removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2011-00012 |
| MDR Report Key | 2185051 |
| Report Source | 00 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-06-29 |
| Date of Event | 2011-05-27 |
| Date Mfgr Received | 2011-06-20 |
| Date Added to Maude | 2011-08-08 |
| 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 | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE CLIP |
| Generic Name | NONE |
| Product Code | HGB |
| Date Received | 2011-07-07 |
| Model Number | AVM-851 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-07 |