MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-05-16 for RING APPLICATOR SET, 45 DEGREE (085.096) INTRAUTERINE TUBE 40 MM-45 D 084.067 manufactured by Nucletron Corp..
[61338]
The hinge or small hook (part #084. 501) broke off of the intrauterine tube (part #084. 067) and remained in the pt after the 45 degree ring applicator (#085. 096) was extracted from the pt. The broken piece was later retrieved from the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121753-1997-00009 |
| MDR Report Key | 92138 |
| Report Source | 05 |
| Date Received | 1997-05-16 |
| Date of Report | 1997-05-15 |
| Date of Event | 1996-05-23 |
| Date Facility Aware | 1996-05-23 |
| Report Date | 1997-05-15 |
| Date Reported to Mfgr | 1997-05-25 |
| Date Added to Maude | 1997-05-22 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RING APPLICATOR SET, 45 DEGREE (085.096) |
| Generic Name | GYNECOLOGICAL APPLICATOR (COMPONENT OF) |
| Product Code | HGD |
| Date Received | 1997-05-16 |
| Returned To Mfg | 1996-05-24 |
| Model Number | INTRAUTERINE TUBE 40 MM-45 D |
| Catalog Number | 084.067 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 91008 |
| Manufacturer | NUCLETRON CORP. |
| Manufacturer Address | WAARDGELDER 1 TH VEENENDAAL NL 3905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-16 |