MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-25 for GLUTEAL IMPLANT, ROUND, TEXTURED, SDM N/A CCB6-T-84 manufactured by Implantech Associates, Inc..
[98424068]
Method: the actual device was returned and gross visual examination and examination under magnification was performed. A review of manufacturing records and quality control records was also performed. Results: code for "none" selected as no more appropriate code was located. A tear in the circumference of the device was observed. Conclusion: breakage or damage to medical devices on implantation is a known risk of the procedure. Product labeling warns that a prosthesis that appears damaged should not be implanted.
Patient Sequence No: 1, Text Type: N, H10
[98424069]
Complainant reported that they received a gluteal implant that contained bubbles. They proceeded to insert the implant into a keller funnel, and it ripped. The problem occurred before there was any patient contact, and they had a backup available so there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00001 |
| MDR Report Key | 7219175 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date of Event | 2018-01-03 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2017-10-10 |
| Date Added to Maude | 2018-01-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUTEAL IMPLANT, ROUND, TEXTURED, SDM |
| Generic Name | GLUTEAL IMPLANT |
| Product Code | MIB |
| Date Received | 2018-01-25 |
| Returned To Mfg | 2018-01-10 |
| Model Number | N/A |
| Catalog Number | CCB6-T-84 |
| Lot Number | 873720 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |