MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-02-20 for TIO2MESH MFP111 manufactured by Biocer Entwicklungsgmbh.
[5629180]
Biocer b)(4) has been informed by (b)(4), division medical devices, (b)(4) on a potential complication using tio2mesh surgical mesh implants. In a few exceptional cases and only under certain conditions it can happen that after an incision parallel to the blue orientation stripes a so-called ladder is formed and a propagation of the tear without any force effect will result. The problem is noted prior use of the device. To prevent this eventuality in future, biocer extends the instructions for use of tio2mesh with a waring: incisions and cavities parallel to the blue orientation stripes should generally be avoided. For indications in which an incision is required specially manufactured mesh implants are provided by the manufacturer. Biocer has already received the ncar from (b)(4). Considers this corrective action to be sufficient for risk reduction. The product tio2mesh is not yet distributed in the usa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009749957-2015-00001 |
| MDR Report Key | 4605881 |
| Report Source | 00 |
| Date Received | 2015-02-20 |
| Date of Report | 2014-10-13 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-10-13 |
| Device Manufacturer Date | 2013-11-13 |
| Date Added to Maude | 2015-04-17 |
| 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 | MARTINA FELDMAN |
| Manufacturer Street | LUDWIGTHOMASTRASSE 36C |
| Manufacturer City | BAYREUTH 95447 |
| Manufacturer Country | GM |
| Manufacturer Postal | 95447 |
| Manufacturer Phone | 2178777075 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIO2MESH |
| Generic Name | SURGICAL MESH IMPLANT |
| Product Code | OXJ |
| Date Received | 2015-02-20 |
| Model Number | MFP111 |
| Lot Number | 130928 |
| ID Number | NO DISTRIBUTION |
| Device Expiration Date | 2016-11-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCER ENTWICKLUNGSGMBH |
| Manufacturer Address | LUDWIGTHOMASTRASSE 36C BAYREUTH 95447 GM 95447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-20 |