MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-04-24 for ESO-SPONGE OV.13MM 5526550 manufactured by B. Braun Surgical S.a..
[5586628]
Country of complaint: (b)(6). Complaint states: the tube has detached form the sponge/while replacing it. After that, they have tried to get the sponge out with a so called endo -forceps. The head physician told, that it only was possible to recover the sponge bit by bit. The sponge was placed inside the patient for five days until the replacement. The sponge was placed inside a cavity, which had contact with the stomach, so that the gastric acid was able to get contact with the sponge itself.
Patient Sequence No: 1, Text Type: D, B5
[13258939]
Reported device is not marketed in the u. S. ; however, device(s) that share components and/or raw materials are. Evaluation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00353 |
| MDR Report Key | 4734323 |
| Report Source | 01,07 |
| Date Received | 2015-04-24 |
| Date of Report | 2015-04-22 |
| Date Mfgr Received | 2015-03-24 |
| Date Added to Maude | 2015-06-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | 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 | ES |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESO-SPONGE OV.13MM |
| Generic Name | SPONGE, SCRUB |
| Product Code | GEC |
| Date Received | 2015-04-24 |
| Model Number | 5526550 |
| Catalog Number | 5526550 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL S.A. |
| Manufacturer Address | RUBI (BARCELONA) 08191 ES 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-24 |