MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-02-11 for ARTELON TISSUE REINFORCEMENT manufactured by Artimplant Ab.
[3185417]
An artelon tissue reinforcement patch was used in reinforcement of a chronic achilles tendon rupture. The device was explanted on (b)(6) 2013 due to irritation, redness and minor swelling over the previous incision site. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10577361]
At explantation the dr noted that the initial rupture had healed successfully and the explantation proceeded w/o complications. The dr suspected a reaction towards the sutures (fiberwire and unspecified absorbable sutures) not the device. No conclusion can be drawn since the device is not available for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004878714-2013-00001 |
| MDR Report Key | 2969017 |
| Report Source | 08 |
| Date Received | 2013-02-11 |
| Date of Report | 2013-02-08 |
| Date of Event | 2013-01-11 |
| Date Mfgr Received | 2013-01-15 |
| Date Added to Maude | 2013-02-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | HULDA MELLGRENS GATA 5 |
| Manufacturer City | VASTRA FROLUNDA SE-421 32 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-421 32 |
| Manufacturer Phone | 17465600 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTELON TISSUE REINFORCEMENT |
| Generic Name | ATR |
| Product Code | KYI |
| Date Received | 2013-02-11 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTIMPLANT AB |
| Manufacturer Address | VASTRA FROLUNDA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-11 |