SEPRAMESH IP Adverse Event — Injury (MDR 1213643-2020-04032)
SEPRAMESH IP Adverse Event — Injury (MDR 1213643-2020-04032) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SEPRAMESH IP; Generic name: SURGICAL MESH; Manufacturer: DAVOL INC., SUB. C.R. BARD, INC..
| Device | SEPRAMESH IP |
|---|---|
| Generic name | SURGICAL MESH |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Report number | 1213643-2020-04032 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | Other, Consumer |
| Narrative | AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. H.11: THIS IS AN ADDENDUM TO THE INITIAL EMDR SUBMITTED (1213643-2020-04032). THIS SUPPLEMENTAL EMDR IS SUBMITTED TO REPORT THE ADDITIONAL PRODUCT AND EVENT DETAILS P |
| Source | openFDA MAUDE (device adverse events) |
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