MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML 1050052 manufactured by B. Braun Surgical S.a..
[122803977]
(b)(4). Reported device not marketed in the u. S. , however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u. S. Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[122803978]
It was reported that an ampoule of tissue adhesive was found to be leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00612 |
| MDR Report Key | 7931696 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-08-08 |
| Date Facility Aware | 2018-11-29 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-10-03 |
| 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 | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| 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 | 0 |
| Brand Name | HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML |
| Generic Name | TISSUE ADHESIVE |
| Product Code | PJK |
| Date Received | 2018-10-03 |
| Returned To Mfg | 2018-09-24 |
| Model Number | 1050052 |
| Catalog Number | 1050052 |
| Lot Number | 217084N1 |
| Device Expiration Date | 2019-01-31 |
| 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 S.A. |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI (BARCELONA), 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-03 |