MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for SC UPMD SET 75652 manufactured by B.braun Surgical Sa.
[110242067]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[110242068]
Country of complaint: (b)(6). It was reported needle detachment and thread breakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00348 |
| MDR Report Key | 7563053 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-04-25 |
| Date Facility Aware | 2018-05-30 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-06-01 |
| 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 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 | SC UPMD SET |
| Generic Name | SUTURES |
| Product Code | GAK |
| Date Received | 2018-06-01 |
| Returned To Mfg | 2018-05-22 |
| Model Number | 75652 |
| Catalog Number | 75652 |
| Lot Number | P180207005 |
| 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 | 1. Other | 2018-06-01 |