MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-08-04 for RING APPLICATOR 084.067 manufactured by Nucletron Bv.
[21379454]
Ring applicator part #084. 087 was purchased 2/22/95 with the mhdr unit and was unused until the date of the report to nucletron. On that date, the applicator was taken from the kit where it was stored, inspected prior to clinical use, at which time the ring end of the applicator became detached from the applicator shaft. The incident was reported to nucletron and a replacement applicator was provided. It was determined that tech note #300. 048, which informs the user of the possibility that the ring may separate was delivered to the clinician when the unit was commissioned. This tech note instructs the weld at the site where the ring joins the applicator should be inspected prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121753-1997-00017 |
| MDR Report Key | 117352 |
| Report Source | 05 |
| Date Received | 1997-08-04 |
| Date of Report | 1997-08-04 |
| Date of Event | 1997-04-11 |
| Date Facility Aware | 1997-04-11 |
| Report Date | 1997-08-04 |
| Date Mfgr Received | 1997-04-11 |
| Date Added to Maude | 1997-09-05 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RING APPLICATOR |
| Generic Name | GYNECOLOGICAL APPLICATOR (COMPONENT OF |
| Product Code | HGD |
| Date Received | 1997-08-04 |
| Model Number | RING APPLICATOR |
| Catalog Number | 084.067 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 115090 |
| Manufacturer | NUCLETRON BV |
| Manufacturer Address | WAARGELDER 1 3905 TH VEEDEDAAL * NL |
| Baseline Brand Name | RING APPLICATOR |
| Baseline Generic Name | GYNECOLOGICAL APPLICATOR (COMPONENT OF |
| Baseline Model No | RING APPLICATOR |
| Baseline Catalog No | 084.087 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-04 |