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 2020-02-17 for MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE 41167201 manufactured by B.braun Surgical Sa.
[179728691]
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. K991223. When additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[179728692]
It was reported that the thread is brittle and keeps snapping. The reporter indicated a practice returned a cassette of 3m catgut in which the thread seemed to have gone very brittle and kept fraying and breaking. Additional information has not been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00099 |
| MDR Report Key | 9717660 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-02-17 |
| 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 | MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE |
| Generic Name | CATGUT CHROM CASSETTES |
| Product Code | GAL |
| Date Received | 2020-02-17 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 41167201 |
| Catalog Number | 41167201 |
| Lot Number | 618303 |
| 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 | 2020-02-17 |