MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-04-23 for DILAPAN-S 4X65MM NA manufactured by Medicem Technology S.r.c..
[20701459]
Dilapan-s broke during extraction.
Patient Sequence No: 1, Text Type: D, B5
[20864602]
Complaint forwarded distributor in (b)(4) to manufacturer. Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003994796-2013-00001 |
| MDR Report Key | 3142456 |
| Report Source | 01,05 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-08 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-06-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | KARLOVARSKA TRIDA 20 |
| Manufacturer City | KAMENNE ZEHROVICE 273 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal | 273 01 |
| Manufacturer Phone | 317070370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DILAPAN-S |
| Generic Name | DILAPAN-S HYGROSCOPIC CERVICAL DILATOR |
| Product Code | LOB |
| Date Received | 2013-04-23 |
| Model Number | 4X65MM |
| Catalog Number | NA |
| Lot Number | DS270312465 |
| ID Number | NA |
| Device Expiration Date | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICEM TECHNOLOGY S.R.C. |
| Manufacturer Address | KARLOVARSKA 20 KAMENNE ZEHROVICE 27301 EZ 27301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-23 |