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 CLEAR SKIN ADHESIVE (FP) TS1050071FP manufactured by B. Braun Surgical Sa.
[180919329]
K111959 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
[180919330]
It was reported that there was an issue with histoacryl clear skin adhesive. The customer reported "we are seeing multiple tubes that are cloudy and not clear. " further information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00125 |
| MDR Report Key | 9755064 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2020-02-11 |
| 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 SALUD ORUS |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 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 CLEAR SKIN ADHESIVE (FP) |
| Generic Name | TISSUE ADHESIVES |
| Product Code | MPN |
| Date Received | 2020-02-26 |
| Model Number | TS1050071FP |
| Catalog Number | TS1050071FP |
| Lot Number | 219265N1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 |