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 2019-12-31 for CATGUT PLAIN 5 (9) 25M F1144111 manufactured by B.braun Surgical Sa.
[173300293]
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. No code available 3191 (veterinary case). If additional information becomes available a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[173300354]
It was reported that the thread broke after surgery. The reporter indicated that a veterinary case (cow) required a cesarean section. The uterus was sutured using the catgut. The peritoneum was sutured with vicryl and the skin was sutured with supramid white. One to two days post-operative the cow developed complications: not eating, gas inside abdomen and peritonitis. Via rectal exploration, it was noted the animal had a temperature of 40 degrees celsius. Measures taken by the surgeon: the catgut was replaced with another catgut. Per the reporter the consequences of the incident: the animal was sick with peritonitis and not able to inseminate again. The animal died seven days post operatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2019-00943 |
| MDR Report Key | 9536296 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-31 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2019-12-31 |
| 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 ORUS |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUBI, BARCELONA 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATGUT PLAIN 5 (9) 25M |
| Generic Name | OTHER SUTURE |
| Product Code | GAL |
| Date Received | 2019-12-31 |
| Model Number | F1144111 |
| Catalog Number | F1144111 |
| Lot Number | 618185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-12-31 |