MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML 1050071 manufactured by B. Braun Surgical Sa.
[180919569]
K140343 pma/510k: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. When additional information/investigation results become available, results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[180919570]
It was reported that there was an issue with the histoacryl translucent. The customer reported that there was crystallization at the end of the applicator. Used for inguinal hernias. Further information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00122 |
| MDR Report Key | 9755041 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-02-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SILVIA ORUS |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUBI, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B/ BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML |
| Generic Name | TISSUE ADHESIVES |
| Product Code | MPN |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 1050071 |
| Catalog Number | 1050071 |
| Lot Number | 219351N2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |