MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-28 for LAP-BAND manufactured by Apollo Endosurgery Inc..
[131939545]
Some years after laparoscopic placement of a lapband device to treat obesity, developed left sided pain. Imaging showed that the band between the port and lapband had fractured. The device was laparoscopically removed. In going through hospital line records i came across the gross pathology report. Lap gastric band and port: gross examination performed. Clinical: prolapsed band. Gross: the specimen is received fresh in a container labeled with the patient? S name,? (b)(6)? , the medical record number, and? Lap gastric band and port?. It consists of two pieces of white plastic and metal. One portion measures 18 cm in length x up to 1. 5 cm in diameter. The other portion measures 40 cm in length and consists of plastic tubing with a diameter of 0. 4 cm and a metal and plastic port measuring 3 x 3 x 1. 5 cm. Inscribed on the metal part of the port is:? Port-a-cath m52996?. The specimen is received for gross examination and was reviewed by dr. (b)(6). Gross pathology specimen in two pieces - the lapband and the port. Note that the reporting physician is the patient. Diagnosis or reason for use: obesity. Is the product compounded? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082680 |
| MDR Report Key | 8206273 |
| Date Received | 2018-12-28 |
| Date of Event | 2013-05-13 |
| Date Added to Maude | 2018-12-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LAP-BAND |
| Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Product Code | LTI |
| Date Received | 2018-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY INC. |
| Brand Name | PORT-A-CATH |
| Generic Name | CATHETER INTRODUCER KIT |
| Product Code | OFD |
| Date Received | 2018-12-28 |
| Model Number | PORT-A-CATH |
| Lot Number | M52996 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-28 |