COMPOSIX MESH E/X Adverse Event — Injury (MDR 1213643-2020-04149)
COMPOSIX MESH E/X Adverse Event — Injury (MDR 1213643-2020-04149) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COMPOSIX MESH E/X; Generic name: SURGICAL MESH; Manufacturer: DAVOL INC., SUB. C.R. BARD, INC..
| Device | COMPOSIX MESH E/X |
|---|---|
| Generic name | SURGICAL MESH |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Report number | 1213643-2020-04149 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | CONSUMER, OTHER |
| Narrative | AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED CHRONIC AND SEVERE PAIN, CHRONIC INFLAMMATION, GIANT CELL REACTION, INFECTION, ADHESIONS, NECROSIS, INJURY, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT AND SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. A REVIEW OF THE IFU FINDS IT TO BE ADEQUATE. REVIEW |
| Source | openFDA MAUDE (device adverse events) |
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