MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-01-14 for SAFIL UNDYED 0 (3,5) 70CM HS23 (M) C1049432 manufactured by B. Braun Surgical S.a..
[4454244]
Country of complaint: (b)(6). The needle became detached and remained stuck in the abdominal wall. Search under x-ray used to extract needle.
Patient Sequence No: 1, Text Type: D, B5
[11872526]
Us agent notified on (b)(4) 2013. Reported device not marketed in the us; however similar device is. Evaluation of product of this lot/batch number from stock on-going at manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00017 |
| MDR Report Key | 3821392 |
| Report Source | 01,07 |
| Date Received | 2014-01-14 |
| Date of Report | 2014-01-10 |
| Date of Event | 2013-11-03 |
| Date Mfgr Received | 2013-12-12 |
| Date Added to Maude | 2014-06-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | B. BRAUN SURGICAL S.A. |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, (BARCELONA) 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFIL UNDYED 0 (3,5) 70CM HS23 (M) |
| Generic Name | NONE |
| Product Code | GDL |
| Date Received | 2014-01-14 |
| Model Number | C1049432 |
| Catalog Number | C1049432 |
| Lot Number | 112297 |
| Device Expiration Date | 2017-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL S.A. |
| Manufacturer Address | RUBI, (BARCELONA) 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-14 |