MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-10 for REFORM CAPSULAR TENSION RING ACTR12 manufactured by Morcher Gmbh.
[5220668]
A nurse reported that during the insertion of a capsular tension ring the surgeon noticed a defect causing a capsular tear. Additional information was provided that this was a complicated case. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[12704244]
Evaluation summary: the sample has not returned. Product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. Attempts have been made to obtain additional information by phone and fax. A completed questionnaire has not been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2014-00072 |
| MDR Report Key | 4338095 |
| Report Source | 05 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-11-17 |
| Date Mfgr Received | 2014-11-17 |
| Date Added to Maude | 2014-12-18 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | MORCHER GMBH |
| Manufacturer Street | KAPUZINERWEG 12 |
| Manufacturer City | STUTTGART, WURTTEMBERG-BADEN D-70374 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-70374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFORM CAPSULAR TENSION RING |
| Generic Name | CAPSULAR TENSION RING |
| Product Code | MRJ |
| Date Received | 2014-12-10 |
| Model Number | ACTR12 |
| Catalog Number | ACTR12 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORCHER GMBH |
| Manufacturer Address | KAPUZINERWEG 12 STUTTGART, WURTTEMBERG-BADEN D-70374 GM D-70374 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-10 |