MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-10-20 for UNIGYN BIOPSY PUNCH 1001 * manufactured by Intech Medical.
[503899]
A potential distributor has informed us that three sachets were perforated in their box of 25. Perforation caused by the device itself, event giving a defect of sterility. Acting of samples, we do not have any guarantee as for the handling of the sachets by another person other than a health professional. It acts of an isolated case on 3956 devices distributed to date.
Patient Sequence No: 1, Text Type: D, B5
[7801529]
The distributor has been informed of the risk of perforation of the sachet, and we are requesting to stop any sale of this device. A letter of warning will be sent to him reminding what is already written on the instruction of use enclosed on each box of devices, that "do not use if the package is damaged. " we are asking our distributor to forward this letter to his customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611579-2005-00001 |
| MDR Report Key | 761317 |
| Report Source | 08 |
| Date Received | 2005-10-20 |
| Date of Report | 2005-10-07 |
| Date of Event | 2005-10-05 |
| Date Mfgr Received | 2005-10-05 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-09-19 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 158 RUE DE L'EGLISE |
| Manufacturer City | RANG DU FLIERS |
| Manufacturer Country | FR |
| Manufacturer Phone | 21896000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIGYN BIOPSY PUNCH |
| Generic Name | BIOPSY PUNCH |
| Product Code | EME |
| Date Received | 2005-10-20 |
| Returned To Mfg | 2005-10-07 |
| Model Number | 1001 |
| Catalog Number | * |
| Lot Number | 3963/2 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749224 |
| Manufacturer | INTECH MEDICAL |
| Manufacturer Address | * RANG DU FLIERS FR |
| Baseline Brand Name | UNIGYN BIOPSY PUNCH |
| Baseline Generic Name | BIOPSY PUNCH |
| Baseline Model No | 1001 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-20 |