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 2016-08-11 for SUTURES manufactured by B.braun Surgical Sa.
[51929875]
(b)(4). Product item number was not reported, no additional information surrounding reported event was received; evaluation of claim can not be carried out.
Patient Sequence No: 1, Text Type: N, H10
[51929876]
Country of complaint: (b)(6). It has been reported that the resident physician has repeatedly noted redness at the injection site and in some cases threads coming up when using sutures (cat # c0068597 - novosyn violet). It was reported that the sutures were used for hypodermis. The physician stated he creates 4 knots single-button sutures and uses skin clips during the procedure. After 2-3 weeks the physician removed the skin clips and found pus at the thread site. The physician reopened the wound and took care of the site again. On july 13, 2016 additional information was received that the physician stated that this reported issue has involved approximately 10-20 patients in 2015 and 4-5 patients in 2016. Mdr filed that are associated with this reported 4-5 patients in 2016 include: 2916714-2016-00589 (submitted 7/25/16), 2916714-2016-00590 (submitted 7/26/16), 2916714-2016-00591 (submitted 7/26/16), 2916714-2016-00592 (submitted 7/26/16), 2916714-2016-00593 (submitted 7/26/16), 2916714-2016-00631 (submitted 7/26/16), 2916714-2016-00632 (submitted 7/26/16). Additional information regarding the 10-20 additional patients has been requested multiple times. No additional information has been received, therefore, 20 additional med watch reports are being submitted to accommodate alleged 20 additional patients affected in 2015. These include: 2916714-2016-00684, 2916714-2016-00685, 2916714-2016-00686, 2916714-2016-00687, 2916714-2016-00688, 2916714-2016-00689, 2916714-2016-00690, 2916714-2016-00691, 2916714-2016-00692, 2916714-2016-00693, 2916714-2016-00694, 2916714-2016-00695, 2916714-2016-00696, 2916714-2016-00697, 2916714-2016-00698, 2916714-2016-00699, 2916714-2016-00700, 2916714-2016-00701, 2916714-2016-00702, 2916714-2016-00703. This is report 14 of 20.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00697 |
| MDR Report Key | 5870383 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-11 |
| Date of Report | 2016-08-11 |
| Date Facility Aware | 2016-07-25 |
| Date Mfgr Received | 2016-07-13 |
| Date Added to Maude | 2016-08-11 |
| 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, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SUTURES |
| Product Code | GAK |
| Date Received | 2016-08-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-11 |