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 |